Cooling Eyedrops for Dry Eye Syndrome
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.12345Why 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive acoltremon (TRYPTYR) 0.003% eye drops or placebo to assess impact on tear lipid layer thickness and tear thinning rate
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
25 subjects will be randomized to receive the Treatment eye drops.
25 subjects will be randomized to receive the Control eye drops.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Berkeley
Lead Sponsor
Alcon Research
Industry Sponsor
Raquel C. Bono
Alcon Research
Chief Medical Officer since 2022
MD from Harvard Medical School
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 ...
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optometrytimes.com
optometrytimes.com/view/fda-approves-alcon-s-tryptyr-ar-15512-for-signs-and-symptoms-of-dry-eye-diseaseFDA 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 ...
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