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

Phase 4

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: Placebo; Drug: Azithromycin Ophthalmic Solution, 1%

• Registration Number: NCT01014078
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-12
• Study First Submitted QC: 2009-11-13
• Study First Posted: 2009-11-16
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Disposition First Submitted: 2011-01-13
• Disposition First Submitted QC: 2011-01-13
• Disposition First Posted: 2011-01-28
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-20
• Last Update Posted: 2011-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Azithromycin Ophthalmic Solution, 1%	Azithromycin Ophthalmic Solution, 1%	-

Primary Outcome Measures

Name	Time	Method
Tear Break-Up Time (TBUT)	4 weeks

Secondary Outcome Measures

Name	Time	Method
Corneal Staining	4 weeks
Tear Volume	4 weeks
Meibomian gland plugging	4 weeks
Subject-rated scores of dry eye symptoms	4 weeks

Trial Locations

Locations (9)

Abrams Eye Center; 🇺🇸 Cleveland, Ohio, United States

OSU - College of Optometry; 🇺🇸 Columbus, Ohio, United States

Sall Research Medical Center, Inc.; 🇺🇸 Artesia, California, United States

Tauber Eye Center; 🇺🇸 Kansas City, Missouri, United States

Eye Clinics of South Texas; 🇺🇸 San Antonio, Texas, United States

Kentucky Lions Eye Center; 🇺🇸 Louisville, Kentucky, United States

Ophthalmology Associates; 🇺🇸 Saint Louis, Missouri, United States

David Wirta, MD, Inc.; 🇺🇸 Newport Beach, California, United States

North Bay Eye Associates, Inc.; 🇺🇸 Petaluma, California, United States