Cooling Eyedrops for Dry Eye Syndrome

MC
Overseen ByMeng C Lin, OD, PhD
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests eyedrops called acoltremon (TRYPTYR) to determine if they can help people with evaporative dry eye by increasing the tear film's lipid layer and slowing tear evaporation. The goal is to improve dry eye symptoms by stimulating a cooling sensation on the eye surface, potentially boosting natural tear and oil production. Participants will receive either the treatment eyedrops or a placebo to compare results. The trial seeks individuals diagnosed with evaporative dry eye in the last 6 months who have not recently used certain eye medications or contact lenses. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.

What is the safety track record for Acoltremon (TRYPTYR) 0.003% eye drops?

Research has shown that acoltremon (TRYPTYR) 0.003% eye drops are generally safe for treating dry eye syndrome. In earlier studies involving individuals with dry eye disease, these eye drops increased tear production, and few participants discontinued use due to side effects. This suggests that most people can use the drops without issues.

The U.S. Food and Drug Administration (FDA) has approved acoltremon for dry eye disease, indicating it has passed safety checks for this purpose. However, like any treatment, users should monitor for any discomfort or issues. A common tip is to avoid touching the vial tip to the eye to prevent contamination or injury. Overall, past evaluations have shown acoltremon eye drops to be safe.12345

Why are researchers enthusiastic about this study treatment?

Unlike standard treatments for dry eye syndrome, which typically focus on artificial tears or anti-inflammatory medications, Acoltremon (TRYPTYR) eye drops are unique because they incorporate a cooling effect. This innovative approach not only provides immediate soothing relief but also helps to reduce inflammation by lowering the temperature of the ocular surface. Researchers are excited about Acoltremon because its dual-action mechanism could offer faster and more effective relief for those suffering from dry eye symptoms.

What evidence suggests that acoltremon eye drops might be an effective treatment for dry eye syndrome?

Research has shown that acoltremon (TRYPTYR) 0.003% eye drops effectively treat dry eye syndrome. One study reported that 42.6% of patients experienced a significant increase in tear production, with at least a 10-mm increase in natural tears. Another study found even better results, with 53.2% of patients experiencing the same improvement. These findings suggest that the eye drops can help many people with dry eye by increasing tear production and improving symptoms. The eye drops activate TRPM8 receptors, creating a cooling sensation that may boost tear and oil production, helping to keep the eyes moist for longer. Participants in this trial will receive either the acoltremon eye drops or a placebo control to further evaluate their effectiveness.678910

Are You a Good Fit for This Trial?

This trial is for people with dry eye syndrome, especially those whose eyes don't make enough tears or whose tears evaporate too quickly. Participants should not have other major eye conditions or recent eye surgeries.

Inclusion Criteria

Able and willing to comply with visit schedule
Baseline LipiView tear lipid layer thickness ≤50nm
Able and willing to undergo all planned assessments
See 4 more

Exclusion Criteria

Subjects with a condition or situation which may put the subject at significant risk, confound study results, or interfere with participation
Use of contact lenses within 24 hours of study
History of diabetes
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive acoltremon (TRYPTYR) 0.003% eye drops or placebo to assess impact on tear lipid layer thickness and tear thinning rate

2 hours
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Acoltremon (TRYPTYR) 0.003% eye drops

Trial Overview

The study is testing cooling eyedrops containing acoltremon (TRYPTYR) 0.003% to see if they help improve tear quality and reduce dryness compared to a control group. Participants are randomly assigned to either the treatment or control group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention
Group II: ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Berkeley

Lead Sponsor

Trials
193
Recruited
716,000+

Alcon Research

Industry Sponsor

Trials
739
Recruited
128,000+
Raquel C. Bono profile image

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott profile image

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Citations

Tryptyr Ophthalmic Solution Gets FDA Nod for Dry Eye ...

In the COMET-2 study, 42.6% of patients treated with acoltremon ophthalmic solution 0.003% (n=230) achieved at least a 10mm increase in tear ...

Acoltremon produces rapid and sustained outcomes for ...

Acoltremon produces rapid and sustained outcomes for patients with dry eye disease. Ophthalmology 360. In part ...

217370Orig1s000 - accessdata.fda.gov

The Phase 3 studies COMET-2 and COMET-3 are intended to demonstrate efficacy for the treatment of dry eye disease. Refer to Section 15 for a ...

Acoltremon for Dry Eye Syndrome · Info for Participants

Research has shown that Acoltremon effectively treats dry eye syndrome. In studies, Acoltremon 0.003% significantly increased tear production and improved dry ...

FDA approves Alcon's Tryptyr (AR-15512) for signs and ...

COMET-2 saw 42.6% vs 8.2% of patients with at least a 10-mm increase, and COMET-3 saw 53.2% vs 14.4% (both P < .0001). Additionally, it was ...

Acoltremon: First Approval

During phase III trials in patients with dry eye disease, acoltremon demonstrated increased tear production with a low treatment discontinuation rate. This ...

FDA approves Alcon's Tryptyr (AR-15512) for signs and ...

Alcon announced that the FDA has approved acoltremon ophthalmic solution 0.003%, a first-in-class transient receptor potential melastatin 8 ...

Acoltremon (ophthalmic route) - Side effects & dosage

Acoltremon eye drops is used to treat signs and symptoms of dry eye disease. ... Safety and efficacy have not been established. Geriatric.

Label: TRYPTYR- acoltremon solution - DailyMed - NIH

5.1 Potential for Eye Injury and Contamination - To avoid the potential for eye injury and contamination, do not touch the vial tip to the eye or other ...

Alcon's Tryptyr (acoltremon ophthalmic solution) has won FDA ...

Alcon's Tryptyr (acoltremon ophthalmic solution) has won FDA approval for dry eye disease, offering a novel mechanism and quick relief for over ...