A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Rewetting Drops in Subjects With History and Current Complaint of Contact Lens-Related Dry Eye (CLDE)
Overview
The primary objective of this study is to compare the duration of subject reported comfortable contact lens daily wear time in subjects with a history and current complaint of CLDE during a 29-day treatment period of azithromycin ophthalmic solution, 1%, compared to rewetting drops
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: November 2010
Interventions
- Drug: azithromycin ophthalmic solution, 1%
- 1 drop BID for the first 2 days and then 1 drop QD for the remainder of treatment period (29 ± 1 day)
- Drug: Visine® for Contacts®
- 1-2 drops QID for the treatment period (29 ± 1 day)
Arms, Groups and Cohorts
- Experimental: azithromycin ophthalmic solution, 1%
- Experimental: rewetting drops
Clinical Trial Outcome Measures
Primary Measures
- Subject-reported comfortable contact lens daily wear time (hours/day) at Week 4 Endpoint
- Time Frame: 4 weeks
Secondary Measures
- Subject-reported comfortable contact lens daily wear time, excluding Week 4 Endpoint
- Time Frame: 2 weeks
- Subject-reported duration of total contact lens daily wear
- Time Frame: 4 weeks
- Subject-reported rating of overall eye dryness
- Time Frame: 4 weeks
- Contact Lens-Related Dry Eye Questionnaire
- Time Frame: 4 weeks
- Tear hyperosmolarity (mOsm)
- Time Frame: 4 weeks
- Habitual low-contrast visual acuity (LCVA)
- Time Frame: 4 weeks
Participating in This Clinical Trial
Inclusion Criteria
- Have a history of and current complaint of CLDE. – Use properly fitted daily-wear soft contact lenses. – Able to wear contact lenses for at least 8 hours a day. – If female, are non-pregnant or non-lactating. Exclusion Criteria:
- Have changed brand of contact lens or care solutions within one month prior to Visit 1. – Use extended (overnight) wear contact lenses. – Have a clinically significant ophthalmic abnormality. – Have had cauterization of the punctum or have had punctal plugs (silicone or collagen) inserted or removed within the 90 days prior to the screening. – Have any active ongoing ocular infection or ocular disease. – Have a serious medical condition which could confound study assessments.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Provider of Information About this Clinical Study
- Mike Schiewe, Associate Director, Inspire
- Overall Official(s)
- Reza Haque, MD, PhD, Study Chair, Medical Monitor
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