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NCT07848373
Contact Lens-Wearing Dry Eye Subjects Who Are Treated With Acoltremon 0.003%
Conditions: Dry Eye, Contact Lens Discomfort, Eye Drops
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 50
Sponsor: Eye Research Associates, LLC
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.
Eligibility Criteria
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 wearers 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 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.
Source: ClinicalTrials.gov (NCT07848373). StuddyBuddy aggregates publicly available trial information.