A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% in dry eye subjects over a four week treatment period, using placebo as a comparison.

• 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 current diagnosis of dry eye in one or both eyes

• Moderate to severe degree of meibomian gland plugging

• Have best corrected visual acuity in both eyes of at least +0.7 LogMAR

• If female, are non-pregnant or non-lactating

Exclusion Criteria:

• Have anterior blepharitis

• Have lid structural abnormalities

• Have suspected ocular fungal or viral infection

• Have had penetrating intraocular surgery in the past 90 days or require penetrating intraocular surgery during the study

• Have had ocular surface surgery [e.g., laser-assisted in situ keratomileusis (LASIK), refractive, pterygium] within the past year.

• Unable to withhold the use of contact lenses during the study

• Have a known hypersensitivity to azithromycin, erythromycin, any other macrolide antibiotic, or any of the other ingredients in the study medication.

• Have a history of post vitreous detachment.

• Are considered legally blind in 1 eye (LogMAR BCVA= 1.0 or Snellen BCVA= 20/200).

• Have permanent conjunctival goblet cell loss or scarring conditions, including cicatricial blepharitis or conjunctivitis.

• Have a congenitally absent meibomian gland or lacrimal gland.

• 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 a serious medical condition which would confound study assessments.

• Have a concomitant ocular pathology that, in the opinion of the investigator, may confound study assessments.