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)

Completed · Phase 4

Conditions studied: Contact Lens Dry Eye

In brief

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

Key facts

Study ID

NCT01105624

Run by

Merck Sharp & Dohme LLC

People needed

50

Starts

2010-03-01

Expected to finish

2010-11-01

Last updated by the study team

2011-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Ohio State University, College of Optometry — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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