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NCT07848373

PHASE4

Contact Lens-Wearing Dry Eye Subjects Who Are Treated With Acoltremon 0.003%

Sponsor: Eye Research Associates, LLC

View on ClinicalTrials.gov

Summary

Dry Eye Disease is a multifaceted condition which has symptoms such as eye dryness, burning, and stinging sensation in the eyes. As well as clinical diagnosis such as a decreased ability to create tear film. Despite improvements in Contact Lenses (CL) DED still is responsible for a large percentage of CL dropouts due to discomfort. Thus, the purpose of this study is to determine if acoltremon 0.003% can improve the frequency and severity of DED symptoms in CL wearers.

Official title: A Clinical Evaluation of Contact Lens-Wearing Dry Eye Subjects Who Are Treated With Acoltremon 0.003%

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-10

Completion Date

2027-02-21

Last Updated

2026-09-30

Healthy Volunteers

Conditions

Dry Eye Contact Lens Discomfort Eye Drops

Interventions

DRUG

acoltremon 0.003%

Acoltremon 0.003% (TRYPTYR; Alcon Laboratories; Fort Worth, TX, USA) was recently approved by the US Food and Drug Administration (FDA) as the first transient receptor potential melastatin (TRPM8) agonist for the treatment of DED. Acoltremon 0.003% is dosed twice a day

Inclusion Criteria: * • Adult subjects who are ≥18 years of age. * Best corrected CL visual acuity of 0.1 Logarithm of the Minimum Angle of Resolution (logMAR) or better in both eyes (Snellen equivalent 20/25). * Willing to wear a new pair of CLs to the baseline study visit. * Daily, soft, frequent replacement CL wearer (daily disposable, bi-weekly, or monthly CLs). * An Eye Dryness VAS score of ≥40. * CLDEQ-8 scores (CLDEQ-8 scores ≥12). * A score of \>7 dots on the Lexitas NEI staining scale (grade 1 in a single sector on the 5-sector scale). * Habitual wears of soft CLs for a minimum of 5 days per week for 6 hours or more per day during the month prior to enrollment. * Willing to maintain habitual soft CL wear of a minimum of 5 days per week for 6 or more hours per day for the 1 month duration of the study. * Habitual CLs have an acceptable fit (good centration, movement, and coverage Exclusion Criteria: * Any history of acoltremon 0.003% use. * Are currently an overnight CL wearer. * Are currently hard or scleral CL wearers. * Have known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome). * Have a history of ocular surgery within the past 12 months. * Have a history of viral eye disease that may confound study results. * Have a history of severe ocular trauma, active ocular infection or inflammation. * Have ever used using isotretinoin-derivates (e.g., Accutane). * Are currently taking ocular medications (including topical glaucoma medication) or plan to during the study. * Have had a physical meibomian gland treatment withing 1 month of enrollment (iLux, Lipiflow, Radio Frequency and IPL with manual expressions, microblepharoexfoliation etc.). * Have used a prescription DED medication in the last 1 month. * Unwilling to agree to discontinue artificial tear use the day before enrollment and throughout the study. * Have a condition or in a situation, which in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation. * Are pregnant or breast feeding.