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)

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Azithromycin; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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.