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

Completed · Phase 4 · Has a placebo group

Conditions studied: Dry Eye Disease

In brief

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.

Key facts

Study ID

NCT01014078

Run by

Merck Sharp & Dohme LLC

People needed

112

Starts

2009-10-01

Expected to finish

2010-03-01

Last updated by the study team

2011-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Sall Research Medical Center, Inc. — Artesia, California, United States
• David Wirta, MD, Inc. — Newport Beach, California, United States
• North Bay Eye Associates, Inc. — Petaluma, California, United States
• Kentucky Lions Eye Center — Louisville, Kentucky, United States
• Tauber Eye Center — Kansas City, Missouri, United States
• Ophthalmology Associates — St Louis, Missouri, United States
• Abrams Eye Center — Cleveland, Ohio, United States
• OSU - College of Optometry — Columbus, Ohio, United States
• Eye Clinics of South Texas — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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