Acoltremon for Dry Eye Syndrome
((DESERT) Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called Acoltremon for individuals with dry eye syndrome, a condition causing discomfort and vision problems. The goal is to evaluate Acoltremon's effectiveness in real-world settings over short and mid-term periods. This trial suits those who have experienced dry eye issues for at least three months and have significant symptoms. Participants will complete surveys to report changes in their symptoms. As a Phase 4 trial, Acoltremon has already received FDA approval and proven effective, aiding researchers in understanding its benefits for more patients.
Do I have to stop taking my current medications for the trial?
You may need to stop certain medications before joining the trial. If you're using medications like Restasis, Xiidra, or any other topical anti-inflammatory drugs, you'll need to stop them 30 days before the trial and during it. Also, if you're on systemic medications that affect tear production, you must be on a stable dose for more than 30 days.
What is the safety track record for Acoltremon?
Research has shown that Acoltremon, already approved by the FDA for other uses, is generally safe. In past studies, patients tolerated Acoltremon 0.003% well, with most side effects being mild and resolving on their own.
Given its FDA approval, Acoltremon has a strong safety record. Earlier studies reported no serious side effects from the treatment, suggesting that Acoltremon is generally safe for treating dry eye syndrome.12345Why are researchers enthusiastic about this study treatment?
Acoltremon is unique because it offers a new approach to treating Dry Eye Syndrome with its active ingredient, Acoltremon 0.003%. Unlike standard treatments like artificial tears and anti-inflammatory medications, Acoltremon is designed to provide longer-lasting relief by directly addressing the underlying causes of dry eye. Researchers are excited about its potential to improve tear stability and reduce inflammation, offering a more targeted solution compared to existing options.
What is the effectiveness track record for Acoltremon in treating dry eye syndrome?
Research has shown that Acoltremon effectively treats dry eye syndrome. In studies, Acoltremon 0.003% significantly increased tear production and improved dry eye symptoms, with benefits noticeable as early as the first day of use. These improvements lasted for at least 90 days. The treatment targets a receptor called TRPM8, which helps regulate eye moisture. Based on these findings, the FDA has approved Acoltremon for managing dry eye conditions, indicating strong evidence of its effectiveness.13467
Are You a Good Fit for This Trial?
This trial is for individuals with Dry Eye Disease, who often experience discomfort and visual problems due to unstable tear films and inflammation. The study aims to understand how well Acoltremon works in everyday settings over a period of 3 months.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Acoltremon 0.003% and are evaluated using the SPEED questionnaire
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Acoltremon
Trial Overview
The DESERT trial is testing the effectiveness of an FDA-approved treatment called Acoltremon (0.003%) for Dry Eye Syndrome by using surveys to track symptom changes at multiple points during the study.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
all subjects meeing inclusion/exclusion will be dispensed FDA Approved acoltremon 0.003%
Find a Clinic Near You
Who Is Running the Clinical Trial?
Center for Sight Las Vegas
Lead Sponsor
Citations
Acoltremon Ophthalmic Solution 0.003% for Signs and ...
Evidence of tear production in favor of ACO versus VEH was observed as early as day 1 through day 90 in both studies (P < 0.0001). Numerically ...
2.
ophthalmologyadvisor.com
ophthalmologyadvisor.com/news/acoltremon-improves-tear-production-dry-eye/Acoltremon Elicits Sustained Efficacy in Dry Eye Disease
Acoltremon 0.003% ophthalmic solution significantly increased tear production and improved dry eye disease symptoms in two Phase 3 studies.
217370Orig1s000 - accessdata.fda.gov
DED is also known as keratoconjunctivitis sicca, dry eye syndrome ... Summary of Clinical Efficacy for Tryptyr (acoltremon) NDA 217370.
Acoltremon and the TRPM8 frontier: a new chapter in dry ...
In the preceding phase 2b study, 0.003% Acoltremon showed sustained improvements in unanesthetized Schirmer score (Days 1 and 14, p < 0.0001), ...
Acoltremon Ophthalmic Solution 0.003% for Signs and ...
To evaluate the safety and efficacy of the transient receptor potential melastatin 8 agonist acoltremon on signs and symptoms of dry eye disease (DED). Design.
6.
static.cigna.com
static.cigna.com/assets/chcp/pdf/coveragePolicies/pharmacy/ip_0760_coveragepositioncriteria_opthalmology_dry_eye_disease_tryptyr.pdfOphthalmology – Dry Eye Disease – Tryptyr
Tryptyr is not addressed in the AAO dry eye syndrome preferred practice pattern but other FDA-approved therapies for dry eye disease ( ...
Acoltremon Ophthalmic Dosage Guide + Max Dose ...
Usual Adult Dose for Keratoconjunctivitis Sicca. Instill 1 drop in each eye twice a day (about 12 hours apart)
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