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

• Corneal Staining [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Tear Volume [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Meibomian gland plugging [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Subject-rated scores of dry eye symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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.

• Drug: Azithromycin Ophthalmic Solution, 1%
  1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)
• Drug: Placebo
  1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)

• Experimental: Azithromycin Ophthalmic Solution, 1%
  Intervention: Drug: Azithromycin Ophthalmic Solution, 1%
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

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.