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Katherine M. Bickle, Kelly K. Nichols, Reza Haque, Rich C. Zink, Mike Schiewe, Jason J. Nichols; Efficacy of Topical Azithromycin Ophthalmic Solution 1.0% in the Treatment of Contact Lens-Related Dry Eye. Invest. Ophthalmol. Vis. Sci. 2011;52(14):3842.
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To evaluate the safety and efficacy of a 4-week treatment with azithromycin ophthalmic solution 1% for contact lens-related dry eye.
This was a four-week, single-center, open-label clinical study in patients diagnosed with contact lens-related dry eye using the Contact Lens Dry Eye Questionnaire (CLDEQ). Fifty patients were randomized to one of two treatment groups: topical azithromycin solution administered BID on days 1 & 2 and QD on days 3-29 or Visine for Contacts rewetting drops administered QID on days 1-29. Patient diaries were utilized daily to collect data on comfortable and total contact lens wearing time and ocular dryness throughout the treatment period. Tear osmolarity was also assessed.
Fifty patients were enrolled and forty-four completed the study. One patient discontinued in the azithromycin group and five patients discontinued in the rewetting drops group due to adverse events. A significant increase from baseline was observed in the comfortable contact lens wear time for subjects treated with topical azithromycin as compared to subjects treated with rewetting drops at Week 4 (p = 0.004; primary endpoint). Statistical significance was also achieved at Weeks 1, 2 and 3. The improvement in comfortable wear time exceeded 2 hours throughout the treatment period (Weeks 1-4). No significant differences were observed between groups for total wear time or tear osmolarity. Subject-rated ocular dryness (PM time assessments) was significantly improved from baseline in the subjects treated with azithromycin as compared to rewetting drops (entire treatment period; p = 0.02). Additionally, a statistical difference was observed in favor of the azithromycin treatment group at Week 2 for a non-dry eye classification as determined by the CLDEQ (p = 0.05).
Treatment with topical azithromycin ophthalmic solution 1% was well-tolerated and resulted in a significant improvement in comfortable contact lens wear time in patients with contact lens-related dry eye.
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