Cosopt

Migraine, Open-angle glaucoma, Migraine Disorders + 6 more

Treatment

20 Active Studies for Cosopt

What is Cosopt

Timolol

The Generic name of this drug

Treatment Summary

Dorzolamide is a medication used to treat eye conditions such as open-angle glaucoma and ocular hypertension. It works by blocking an enzyme that helps regulate the fluid pressure and ion balance in the eyes. Unlike oral carbonic anhydrase inhibitors, Dorzolamide has minimal effects on acid-base and electrolyte levels, as well as few systemic side effects. It was first released in 1995 and is available as both a stand-alone drug (Trusopt) and a combination drug with Timolol (Cosopt PF).

Timoptic

is the brand name

Cosopt Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Timoptic

Timolol

1978

167

Effectiveness

How Cosopt Affects Patients

Dorzolamide is a medication that lowers pressure in the eye. It is used to treat open-angle glaucoma or ocular hypertension. When combined with other eye medications, Dorzolamide can have a stronger effect on reducing pressure in the eye. This medicine usually starts working within two hours after it is used.

How Cosopt works in the body

Dorzolamide is used to treat ocular hypertension and glaucoma. It works by reducing the amount of fluid produced in the eye, which lowers the intraocular pressure. This drug specifically targets an enzyme called Carbonic Anhydrase II which helps produce bicarbonate ions in the ciliary process of the eye. By inhibiting this enzyme, Dorzolamide reduces sodium and fluid transport, resulting in less fluid and lower intraocular pressure. When intraocular pressure is reduced, it prevents blood flow restrictions and keeps the optic nerve from getting damaged, which would cause vision loss.

When to interrupt dosage

The suggested dosage of Cosopt is contingent upon the diagnosed condition, such as neodynium yttrium aluminum garnet laser posterior capsulotomy, Ocular Hypertension and Increased Intra Ocular Pressure (IOP). The dosage is a function of the administration method (e.g. Solution - Ophthalmic or Solution / drops) outlined in the table below.

Condition

Dosage

Administration

Migraine Disorders

5.0 mg/mL, , 5.0 mg, 10.0 mg, 20.0 mg, 2.5 mg/mL, 6.8 mg/mL, 6.83 mg/mL, 2.56 mg/mL, 5.12 mg/mL, 0.5 %, 0.25 %, 3.4 mg/mL, 0.1 mg/mL

Ophthalmic, Solution - Ophthalmic, Solution, , Oral, Tablet - Oral, Tablet, Solution / drops - Ophthalmic, Solution, gel forming, extended release, Solution, gel forming, extended release - Ophthalmic, Suspension / drops, Suspension / drops - Ophthalmic, Solution / drops, Suspension - Ophthalmic, Suspension, Solution, gel forming / drops - Ophthalmic, Solution, gel forming / drops, Liquid - Ophthalmic, Liquid

Open-angle glaucoma

5.0 mg/mL, , 5.0 mg, 10.0 mg, 20.0 mg, 2.5 mg/mL, 6.8 mg/mL, 6.83 mg/mL, 2.56 mg/mL, 5.12 mg/mL, 0.5 %, 0.25 %, 3.4 mg/mL, 0.1 mg/mL

Ophthalmic, Solution - Ophthalmic, Solution, , Oral, Tablet - Oral, Tablet, Solution / drops - Ophthalmic, Solution, gel forming, extended release, Solution, gel forming, extended release - Ophthalmic, Suspension / drops, Suspension / drops - Ophthalmic, Solution / drops, Suspension - Ophthalmic, Suspension, Solution, gel forming / drops - Ophthalmic, Solution, gel forming / drops, Liquid - Ophthalmic, Liquid

Migraine

5.0 mg/mL, , 5.0 mg, 10.0 mg, 20.0 mg, 2.5 mg/mL, 6.8 mg/mL, 6.83 mg/mL, 2.56 mg/mL, 5.12 mg/mL, 0.5 %, 0.25 %, 3.4 mg/mL, 0.1 mg/mL

Ophthalmic, Solution - Ophthalmic, Solution, , Oral, Tablet - Oral, Tablet, Solution / drops - Ophthalmic, Solution, gel forming, extended release, Solution, gel forming, extended release - Ophthalmic, Suspension / drops, Suspension / drops - Ophthalmic, Solution / drops, Suspension - Ophthalmic, Suspension, Solution, gel forming / drops - Ophthalmic, Solution, gel forming / drops, Liquid - Ophthalmic, Liquid

inadequate response to other therapeutic measures

5.0 mg/mL, , 5.0 mg, 10.0 mg, 20.0 mg, 2.5 mg/mL, 6.8 mg/mL, 6.83 mg/mL, 2.56 mg/mL, 5.12 mg/mL, 0.5 %, 0.25 %, 3.4 mg/mL, 0.1 mg/mL

Ophthalmic, Solution - Ophthalmic, Solution, , Oral, Tablet - Oral, Tablet, Solution / drops - Ophthalmic, Solution, gel forming, extended release, Solution, gel forming, extended release - Ophthalmic, Suspension / drops, Suspension / drops - Ophthalmic, Solution / drops, Suspension - Ophthalmic, Suspension, Solution, gel forming / drops - Ophthalmic, Solution, gel forming / drops, Liquid - Ophthalmic, Liquid

insufficient response to beta-blockers

5.0 mg/mL, , 5.0 mg, 10.0 mg, 20.0 mg, 2.5 mg/mL, 6.8 mg/mL, 6.83 mg/mL, 2.56 mg/mL, 5.12 mg/mL, 0.5 %, 0.25 %, 3.4 mg/mL, 0.1 mg/mL

Ophthalmic, Solution - Ophthalmic, Solution, , Oral, Tablet - Oral, Tablet, Solution / drops - Ophthalmic, Solution, gel forming, extended release, Solution, gel forming, extended release - Ophthalmic, Suspension / drops, Suspension / drops - Ophthalmic, Solution / drops, Suspension - Ophthalmic, Suspension, Solution, gel forming / drops - Ophthalmic, Solution, gel forming / drops, Liquid - Ophthalmic, Liquid

requiring adjunctive or replacement therapy

5.0 mg/mL, , 5.0 mg, 10.0 mg, 20.0 mg, 2.5 mg/mL, 6.8 mg/mL, 6.83 mg/mL, 2.56 mg/mL, 5.12 mg/mL, 0.5 %, 0.25 %, 3.4 mg/mL, 0.1 mg/mL

Ophthalmic, Solution - Ophthalmic, Solution, , Oral, Tablet - Oral, Tablet, Solution / drops - Ophthalmic, Solution, gel forming, extended release, Solution, gel forming, extended release - Ophthalmic, Suspension / drops, Suspension / drops - Ophthalmic, Solution / drops, Suspension - Ophthalmic, Suspension, Solution, gel forming / drops - Ophthalmic, Solution, gel forming / drops, Liquid - Ophthalmic, Liquid

Glaucoma

5.0 mg/mL, , 5.0 mg, 10.0 mg, 20.0 mg, 2.5 mg/mL, 6.8 mg/mL, 6.83 mg/mL, 2.56 mg/mL, 5.12 mg/mL, 0.5 %, 0.25 %, 3.4 mg/mL, 0.1 mg/mL

Ophthalmic, Solution - Ophthalmic, Solution, , Oral, Tablet - Oral, Tablet, Solution / drops - Ophthalmic, Solution, gel forming, extended release, Solution, gel forming, extended release - Ophthalmic, Suspension / drops, Suspension / drops - Ophthalmic, Solution / drops, Suspension - Ophthalmic, Suspension, Solution, gel forming / drops - Ophthalmic, Solution, gel forming / drops, Liquid - Ophthalmic, Liquid

Open Angle Glaucoma

5.0 mg/mL, , 5.0 mg, 10.0 mg, 20.0 mg, 2.5 mg/mL, 6.8 mg/mL, 6.83 mg/mL, 2.56 mg/mL, 5.12 mg/mL, 0.5 %, 0.25 %, 3.4 mg/mL, 0.1 mg/mL

Ophthalmic, Solution - Ophthalmic, Solution, , Oral, Tablet - Oral, Tablet, Solution / drops - Ophthalmic, Solution, gel forming, extended release, Solution, gel forming, extended release - Ophthalmic, Suspension / drops, Suspension / drops - Ophthalmic, Solution / drops, Suspension - Ophthalmic, Suspension, Solution, gel forming / drops - Ophthalmic, Solution, gel forming / drops, Liquid - Ophthalmic, Liquid

Ocular Hypertension

5.0 mg/mL, , 5.0 mg, 10.0 mg, 20.0 mg, 2.5 mg/mL, 6.8 mg/mL, 6.83 mg/mL, 2.56 mg/mL, 5.12 mg/mL, 0.5 %, 0.25 %, 3.4 mg/mL, 0.1 mg/mL

Ophthalmic, Solution - Ophthalmic, Solution, , Oral, Tablet - Oral, Tablet, Solution / drops - Ophthalmic, Solution, gel forming, extended release, Solution, gel forming, extended release - Ophthalmic, Suspension / drops, Suspension / drops - Ophthalmic, Solution / drops, Suspension - Ophthalmic, Suspension, Solution, gel forming / drops - Ophthalmic, Solution, gel forming / drops, Liquid - Ophthalmic, Liquid

Warnings

Cosopt Contraindications

Condition

Risk Level

Notes

Lung Diseases, Obstructive

Do Not Combine

Sinus Bradycardia

Do Not Combine

Shock, Cardiogenic

Do Not Combine

Atrioventricular Block

Do Not Combine

Asthma

Do Not Combine

Heart Failure

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Timolol may interact with Pulse Frequency

There are 20 known major drug interactions with Cosopt.

Common Cosopt Drug Interactions

Drug Name

Risk Level

Description

4-Bromo-2,5-dimethoxyphenethylamine

Major

The therapeutic efficacy of 4-Bromo-2,5-dimethoxyphenethylamine can be decreased when used in combination with Timolol.

4-Methoxyamphetamine

Major

The therapeutic efficacy of 4-Methoxyamphetamine can be decreased when used in combination with Timolol.

Abediterol

Major

Timolol may decrease the bronchodilatory activities of Abediterol.

Adrafinil

Major

The therapeutic efficacy of Adrafinil can be decreased when used in combination with Timolol.

Agrostis gigantea pollen

Major

The risk of a hypersensitivity reaction to Agrostis gigantea pollen is increased when it is combined with Timolol.

Cosopt Toxicity & Overdose Risk

The lowest toxic dose of dorzolamide in rats is 1927mg/kg and 1320mg/kg in mice, when taken orally. In the event of an overdose, patients may experience electrolyte imbalances, acidosis, and changes in the central nervous system. Appropriate care should be taken and the patient’s potassium and pH levels should be monitored.

image of a doctor in a lab doing drug, clinical research

Cosopt Novel Uses: Which Conditions Have a Clinical Trial Featuring Cosopt?

34 active clinical trials are currently underway to assess the potential of Cosopt in providing relief for Ocular Hypertension, Increased Intra Ocular Pressure (IOP) and Open Angle Glaucoma.

Condition

Clinical Trials

Trial Phases

Open-angle glaucoma

53 Actively Recruiting

Not Applicable, Phase 3, Phase 4, Early Phase 1, Phase 1, Phase 2

Open Angle Glaucoma

7 Actively Recruiting

Not Applicable, Phase 4, Phase 1, Phase 2

Ocular Hypertension

14 Actively Recruiting

Phase 1, Phase 2, Not Applicable, Phase 4, Phase 3

requiring adjunctive or replacement therapy

0 Actively Recruiting

inadequate response to other therapeutic measures

0 Actively Recruiting

Migraine Disorders

1 Actively Recruiting

Phase 3

Migraine

52 Actively Recruiting

Phase 4, Phase 1, Not Applicable, Phase 3, Phase 2, Early Phase 1

Glaucoma

0 Actively Recruiting

insufficient response to beta-blockers

0 Actively Recruiting

Cosopt Reviews: What are patients saying about Cosopt?

5

Patient Review

11/27/2009

Cosopt for Increased Pressure in the Eye

This medication was prescribed to me by my optometrist when my eye pressure readings suddenly skyrocketed. Within a week and a half, it had dropped back down to the normal range. I've been using it regularly since then with no issues.

5

Patient Review

4/6/2013

Cosopt for Increased Pressure in the Eye

I experienced some leg pain while taking this medication.

5

Patient Review

7/15/2014

Cosopt for Wide-Angle Glaucoma

The drops caused my eyes to burn.

5

Patient Review

1/16/2010

Cosopt for Increased Pressure in the Eye

I've been using this product for a few years now and have always been really pleased with the results.

4

Patient Review

1/20/2009

Cosopt for Increased Pressure in the Eye

Blurred vision is a very annoying side effect. I spent a lot of money on medical testing for tia's but I feel the blurred vision was from the medication.

3.7

Patient Review

11/23/2008

Cosopt for Wide-Angle Glaucoma

Although this product has helped lower my eye pressure, I have noticed that my eyesight has gotten worse since using it.

3.3

Patient Review

8/20/2011

Cosopt for Wide-Angle Glaucoma

I stopped using Cosorpt for a few days and my back pain improved, which leads me to believe that the medicine was causing the issue in the first place. I had been taking it for years without realizing the potential consequences.

3.3

Patient Review

2/11/2014

Cosopt for Wide-Angle Glaucoma

Xalatan did help lower my eye pressure, which was in the upper 20s, but after adding Cosopt per my doctor's orders, I've seen even better results. My pressure is now down to 18. The only side effects I've experienced are occasional and mild; they include a stinging sensation in my eyes for a few moments post-application as well as a bitter taste at the back of my throat.

3

Patient Review

11/17/2008

Cosopt for Wide-Angle Glaucoma

There are times when I really don't like using cosopt because the blurred vision is so bad. It seems to be worse when I'm physically active.

3

Patient Review

6/24/2022

Cosopt for Wide-Angle Glaucoma

The medication works well, but the plastic containers are garbage. Sometimes you get all the contents in the first eye and nothing is left for the second. The current lot that I have is impossible to twist off; I have to cut it off. I've requested that my doctor prescribe Cosopt in a different container, but he wants me to stick with Pf

3

Patient Review

5/26/2010

Cosopt for Increased Pressure in the Eye

I unfortunately had a really negative reaction to these eyedrops. I got migraines, intense eye pain, high blood pressure, and felt very confused.

3

Patient Review

1/17/2021

Cosopt for Increased Pressure in the Eye

I'm experiencing a lot of tearing and itching. Unfortunately, this is the second time I've had to use this medication and I'm having the same side effects.

2.7

Patient Review

1/6/2009

Cosopt for Increased Pressure in the Eye

The medication has been successful in reducing my pressure, but the side effect of blurred vision is tough to deal with.

2

Patient Review

4/5/2018

Cosopt for Increased Pressure in the Eye

The individual plastic packs are difficult to use. If you squeeze too hard all liquid comes in one drop; too soft the liquid gathers into one drop. Some vials had No liquid at all. The fear of losing out an application with each use is not worth the risk.

2

Patient Review

12/8/2007

Cosopt for Increased Pressure in the Eye

1.3

Patient Review

2/5/2019

Cosopt for Increased Pressure in the Eye

The container is not designed well. It's too hard to open, and sometimes the liquid squirts out when you try to twist off the top. Plus, it stings a lot when you put in the drops, which makes me feel faint. I don't know yet how well it works in terms of lowering my blood pressure readings. But based on the packaging alone, this medication is overpriced and not worth it.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about cosopt

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of drug is Cosopt?

"COSOPT contains two different types of medicine: dorzolamide hydrochloride, an ophthalmic carbonic anhydrase inhibitor, and timolol maleate, a beta-blocker."

Answered by AI

What are the side effects of cosopt PF eye drops?

"If you experience any of the following side effects, tell your doctor or pharmacist promptly: Temporary blurred vision, temporary burning/stinging/itching/redness of the eye, watery eyes, dry eyes, feeling as if something is in the eye, sensitivity of eyes to light, strange taste in the mouth, or headache."

Answered by AI

What is the generic name for Cosopt?

"Cosopt pairs the drug timolol with another medication, dorzolamide. Your doctor may prescribe this combination drug if timolol alone is not sufficiently treating your high eye pressure or glaucoma."

Answered by AI

What is Cosopt eye drops used for?

"COSOPT is a medication used to lower the pressure in the eye in the treatment of glaucoma. It is used when beta-blocker eyedrop medicine used alone is not adequate."

Answered by AI

Clinical Trials for Cosopt

Image of Retina Consultants of Delmarva in Easton, United States.

Iopidine for Intraocular Pressure in Eye Conditions

18+
All Sexes
Easton, MD

This is a prospective, randomized, controlled, open-label, single-site investigator-initiated clinical trial. A total of 120 participants will be randomized in a 1:1 ratio either to receive one drop of apraclonidine 1% ophthalmic solution (Iopidine) approximately 20-30 minutes before a clinically indicated intravitreal injection of Eylea HD or Syfovre, or to a control group that will receive no pre-injection study medication. The intravitreal injection is part of the participant's routine clinical care. The research-specific intervention for participants assigned to the Iopidine group is administration of Iopidine. Participants assigned to the control group will receive no pre-injection study medication. Both groups will undergo post-injection IOP assessments at 5, 15, and 30 minutes post-injection and transient-vision-loss assessments.

Phase 4
Waitlist Available

Retina Consultants of Delmarva

Image of Indiana University School Of Optometry in Bloomington, United States.

Netarsudil vs Timolol for Glaucoma

18+
All Sexes
Bloomington, IN

The purpose of this study is to compare how two FDA-approved eye drops: netarsudil (Rhopressa) and timolol, protect nerve cells in the eye of adults with open-angle glaucoma. Both medications lower pressure inside the eye, but researchers want to learn if Rhopressa is more effective at slowing down or preventing the loss of retinal ganglion cells. These cells are essential for sight because they carry visual signals from the eye to the brain. Participants in this study will complete a total of 6 study visits over 12 months: * Participants will spend 6 months using Rhopressa eye drops and 6 months using Timolol eye drops. The order of the two eye drops will be chosen randomly. * At scheduled study visits, researchers will examine participants' eyes and measure eye pressure. * Researchers will take detailed pictures of the back of the eye using a specialized high-resolution camera called adaptive optics optical coherence tomography (AO-OCT). * Participants will also complete specialized visual field testing to measure eye function. Researchers will count and track individual nerve cells over time to determine if one medication offers better protection against cell loss than the other.

Phase 4
Recruiting

Indiana University School Of Optometry

Alcon Research

Image of Theranica Bio-Electronics Inc in Bridgewater, United States.

Remote Electrical Neuromodulation for Migraine

18+
All Sexes
Bridgewater, NJ

Migraine and Fibromyalgia (FM) are chronic pain disorders characterized by altered central pain processing and impaired endogenous pain inhibition. FM presents with widespread musculoskeletal pain, fatigue, sleep disturbance, and cognitive symptoms and is strongly associated with central sensitization. Migraine similarly involves dysfunction of central inhibitory and descending pain modulation, with evidence of abnormal cortical excitability, impaired sensory habituation, and alterations in pain-related evoked potentials. Conditioned Pain Modulation (CPM) is a measure of the body's endogenous pain-inhibitory mechanism, based on the phenomenon whereby the pain evoked by one painful stimulus (the test stimulus) is reduced by the concurrent application of a second, remote nociceptive stimulus (the conditioning stimulus). It is widely regarded as a proxy for the function of descending pain-modulatory pathways. CPM is used as an experimental biomarker of descending pain inhibition across chronic pain conditions, including fibromyalgia and migraine. Studies consistently demonstrate reduced inhibitory responses in both migraine and fibromyalgia compared with healthy controls, indicating a robust deficit in descending pain modulatory systems. Combining a contact heat test stimulus (TS) with a cold pressor conditioning stimulus (CS) is a widely used and validated CPM paradigm. Nerivio, a Remote Electrical Neuromodulation (REN) device, is a non-invasive, non-pharmacological therapy indicated for the acute and preventive treatment of migraine. The REN device is worn on the upper arm and delivers peripheral electrical stimulation to activate CPM-related descending inhibitory pathways and reduce migraine pain. This distal stimulation approach is designed to activate CPM-related circuits by recruiting brainstem pain-regulatory centers and modulating central nociceptive processing. This randomized, double-blind, placebo-controlled trial is designed to assess the effect of a single REN session on CPM and cortical pain processing in adults with migraine or fibromyalgia. Using a standardized CPM induction protocol, the study will evaluate changes in behavioral CPM responses, before, during, and after REN vs. sham stimulation in patients with migraine or fibromyalgia. This study aims to clarify whether REN enhances descending pain inhibition and pain processing in populations with impaired endogenous pain modulation.

Recruiting
Online Trial

Theranica Bio-Electronics Inc

Alit Stark Inbar, PhD

Theranica

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Image of Alberta Children's Hospital in Calgary, Canada.

Treatment for Migraine

8 - 18
All Sexes
Calgary, Canada

Background \& Rationale: One in ten Canadian youth have migraine, a disabling neurological disease that is more common in females and characterized by moderate-severe disabling headaches. Migraine attacks occur in a cycle that begins with a prodromal phase, followed by aura, a pain phase (headache), and finally a postdrome phase when the pain is resolved but other symptoms persist. The prodrome is recognized by \~90% of all youth with migraine, occurs up to 24 hours before headache onset, and consists of a variety of symptoms including, but not limited to, food cravings, fatigue, yawning, mood changes, and sensory hypersensitivity (e.g., light sensitivity). Prodromal symptoms are disabling and frequently graded as moderate to severe. All acute migraine treatments for youth have been studied for use in the pain phase, with the greatest treatment success early in this phase. Unfortunately, only \~1/3 of youth achieve pain freedom within two hours. Recently, a groundbreaking trial found that treatment during the prodrome could prevent the pain phase, although prodromal treatment does not exist for youth. In considering the most innovative, safe, and patient-centered prodromal intervention, remote electrical neuromodulation (REN) is the obvious choice. The investigator's engagement with 175 youth with migraine and their caregivers shows that REN is preferred when pill-based interventions are ineffective or impractical. REN has none of the limitations of pill-based prodromal treatment. The REN device is wearable, battery-operated, worn on the upper arm, and controlled wirelessly by a smartphone application. REN electrically stimulates sensory nerves in the arm below their perceived pain thresholds, but above their depolarization thresholds, to induce a conditioned pain modulation response in the brain to modulate incoming migraine pain signals. Clinical trial and observational studies in youth with migraine have shown REN's safety and efficacy for home-based treatment during the pain phase and led the FDA to clear its use in youth \>8 years. In the adolescent trial, 71% of participants had pain relief at two hours, there were no serious adverse events (AE), and only one device-related AE (transient arm pain) occurred. Also, emerging data show that adults with migraine in the prodrome phase display pain facilitation due to a deficit in pain modulation. Thus, REN's mechanism of action is likely to be more effective during the prodrome vs. the pain phase as it can "turn on" deficient pain modulatory areas earlier when they are most impaired. Research Question \& Objectives: The investigators aim to determine the feasibility of implementing REN treatment during the prodrome to prevent migraine pain in youth with migraine, and hypothesize that: 1. trial design will be feasible 2. REN will be feasible for prodromal treatment, with \>80% of participants using their assigned device to treat a qualifying prodrome. The following feasibility and acceptability outcomes will be measured: 1. proportion of eligible youth that are enrolled into the screening period, subsequently randomized, and treat a qualifying prodrome with REN. 2. recruitment rate, retention, and withdrawals. 3. participant feedback. All secondary outcomes will be reported descriptively, and adverse events will be recorded and reported. Methods: This study will be a pilot randomized, single centre, double-blind, parallel group, sham-controlled trial comparing active to sham REN for the prevention of headache within 24 hours of treating prodromal symptoms in youth with migraine. Participants will be recruited from headache and neurology clinics at the Alberta Children's Hospital. Eligible and consenting participants will complete an intake visit and enter a 60-day screening period where they will complete electronic daily diaries to determine prodrome or headache occurrence and features. Participants with 3-28 qualifying prodromes during screening, where \>75% are followed by a headache within 6 hours, will be randomized 1:1 to treat one qualifying prodrome with active or sham REN over a 60-day treatment period. Participants will be trained on device use and will be instructed to not use any co-interventions during the qualifying prodrome; if headache onsets after the prodrome, participants will be instructed to use their typical acute treatment. During the treated prodrome, a survey will determine the presence, type, and number of prodromal symptoms. Surveys at 2, 24, and 48 hours post-treatment will record the presence or absence of headache, its characteristics, and AEs. The randomization sequence will be prepared by a biostatistician and will follow randomly ordered blocks of four and six, with variable block sizes. Only research pharmacists will have access to this sequence to prepare consecutively numbered blinded and matched study kits. These kits will contain a restricted mobile phone with only the REN software application pre-installed.

Waitlist Available
Online Trial

Alberta Children's Hospital

Serena L Orr

Image of Ophthalmic Consultants of Boston and Boston Eye Surgery & Laser Center in Boston, United States.

ASP2767 for Glaucoma

18+
All Sexes
Boston, MA

Open-angle glaucoma is the most common type of glaucoma, a disease that damages the nerves in the eye and can lead to vision loss. Current treatments include eye drops, laser treatment, and surgery that help lower eye pressure. However, they do not work for everyone, and the disease may continue to worsen over time. Researchers are looking for better ways to treat open-angle glaucoma. This is an early development study of ASP2767 in people with open-angle glaucoma. In this study, ASP2767 will be given to humans for the first time. ASP2767 is a type of treatment called gene therapy. Gene therapy uses a tool called a vector. In this study a harmless virus is used as the vector. The vector delivers genes into specific parts of the body like the eyes. Once in the eyes these genes help nerve cells in the retina make proteins. These proteins are designed to protect the nerves in the eyes and may help slow down or prevent vision loss. The main aims of the study are to check the safety of ASP2767 in people with open-angle glaucoma, how well they tolerate it, and to find the highest dose of ASP2767 people can safely receive. In addition, the study will also look at the effect of ASP2767 on vision in people with open-angle glaucoma. The study has 2 phases. In both phases of the study, ASP2767 will be given as a single injection into one eye only. In phase 1, small groups of people with open-angle glaucoma will receive ASP2767 starting with lower doses and increasing to higher doses in later groups. The people in the study will also receive prophylactic medicines which will help reduce the risk of inflammation after receiving the ASP2767 injection. Phase 1 is an open-label study. This means that people in the study and the researchers will know which treatment people are getting. Any medical problems people have at each dose level in this study will be recorded. This will help find the highest dose of ASP2767 that people can safely receive, which will also be used in phase 2. In phase 2, another larger group of people with open-angle glaucoma will be randomly placed in 1 of 3 groups of equal size. This means each person will have an equal chance of being placed in any of the 3 groups. They will receive either the highest dose of ASP2767 that people safely received in phase 1, or a slightly lower dose of ASP2767, or a sham injection. A sham injection is a procedure that mimics the injection but does not deliver ASP2767 into the eye. To reduce the risk of inflammation due to the injection, people in the study will also receive a prophylactic medicine or placebo depending on the group they are in. The placebo will look like the prophylactic medicine and will be given in a similar way but will not have any active medicine in it. Researchers use sham injections and placebo to make sure any effect they see in people who take ASP2767 is actually caused by the drug. Phase 2 is a double-masked study, meaning neither the people in the study, nor the researchers will know who is given which treatment. All the people in phase 1 and phase 2 will be followed up for about 1 year after receiving the treatment. After receiving their ASP2767 injection, people will visit the clinic on certain days to have health checks. They will also have their vision checked using different eye tests and will give regular blood and urine samples.

Phase 1 & 2
Recruiting

Ophthalmic Consultants of Boston and Boston Eye Surgery & Laser Center

Study Physician

Astellas Pharma Global Development, Inc.

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Image of Advanced Research in Deerfield Beach, United States.

REGN22530 for Glaucoma

18+
All Sexes
Deerfield Beach, FL

This study will test an experimental drug called REGN22530 ("study drug") to see if it can help treat people with primary open angle glaucoma or ocular hypertension. REGN22530 is an experimental drug that is designed to bind with a protein in the eye that has been shown to cause a buildup of fluid inside the eye and cause increased Intraocular Pressure (IOP). REGN22530 attaches to this protein and stops it from working which may allow more fluid to drain out of the eye and decrease the pressure. The study is looking at: * What side effects REGN22530 might cause * How much REGN22530 is in the blood and eye fluid at different times * If the body has any reactions to REGN22530 (which may cause REGN22530 to not work as well) * How the body and eye pressure respond after having REGN22530, which can help researchers understand why REGN22530 works better in some people than others * How well REGN22530 works

Phase 1 & 2
Recruiting

Advanced Research

Clinical Trial Management

Regeneron Pharmaceuticals

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