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

Study Overview
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Brief Summary
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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.

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: Azithromycin Ophthalmic Solution, 1%
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azithromycin Ophthalmic Solution, 1%<br> | Drug: Azithromycin Ophthalmic Solution, 1%<br>* 1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Break-Up Time (TBUT) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Staining |  | 4 weeks | 
| Tear Volume |  | 4 weeks | 
| Meibomian gland plugging |  | 4 weeks | 
| Subject-rated scores of dry eye symptoms |  | 4 weeks |