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)

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

Timeline

Start

2010-03

Primary completion

2010-11

Completion

2010-11

Outcome

Met primary endpoint

paper A statistically significant increase in mean comfortable contact lens wear time from baseline was observed for the subjects treated with azithromycin ophthalmic solution PMID 22157392 ↗

paper as compared with the subjects treated with rewetting drops at week 4 (P=0.004; primary endpoint) PMID 22157392 ↗

Publications

• Nichols JJ, Bickle KM, Zink RC, Schiewe MD, Haque RM, Nichols KK. Safety and efficacy of topical azithromycin ophthalmic solution 1.0% in the treatment of contact lens-related dry eye. Eye Contact Lens. 2012 Mar;38(2):73-9. doi: 10.1097/ICL.0b013e31823ff229.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azithromycin	Small molecule	1 %	Topical
Subject	Visine® for Contacts®	Unknown	—	—

Indications