Abstract
Purpose: :
To evaluate the safety and efficacy of a 4-week treatment with azithromycin ophthalmic solution 1% for contact lens-related dry eye.
Methods: :
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.
Results: :
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).
Conclusions: :
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.
Clinical Trial: :
http://www.clinicaltrials.gov NCT01105624
Keywords: cornea: tears/tear film/dry eye • contact lens • cornea: clinical science