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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01014078
Recruitment Status : Completed
First Posted : November 16, 2009
Last Update Posted : September 26, 2011
Information provided by:
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: Azithromycin Ophthalmic Solution, 1% Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: Azithromycin Ophthalmic Solution, 1% 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)

Placebo Comparator: Placebo 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)

Primary Outcome Measures :
  1. Tear Break-Up Time (TBUT) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Corneal Staining [ Time Frame: 4 weeks ]
  2. Tear Volume [ Time Frame: 4 weeks ]
  3. Meibomian gland plugging [ Time Frame: 4 weeks ]
  4. Subject-rated scores of dry eye symptoms [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01014078

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United States, California
Sall Research Medical Center, Inc.
Artesia, California, United States, 90701
David Wirta, MD, Inc.
Newport Beach, California, United States, 92663
North Bay Eye Associates, Inc.
Petaluma, California, United States, 94954
United States, Kentucky
Kentucky Lions Eye Center
Louisville, Kentucky, United States, 40207
United States, Missouri
Tauber Eye Center
Kansas City, Missouri, United States, 64111
Ophthalmology Associates
Saint Louis, Missouri, United States, 63131
United States, Ohio
Abrams Eye Center
Cleveland, Ohio, United States, 44115
OSU - College of Optometry
Columbus, Ohio, United States, 43210
United States, Texas
Eye Clinics of South Texas
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Study Chair: Reza Haque, MD, PhD Medical Monitor
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Responsible Party: Mike Schiewe, Associate Director, Inspire Identifier: NCT01014078    
Other Study ID Numbers: 041-116
First Posted: November 16, 2009    Key Record Dates
Last Update Posted: September 26, 2011
Last Verified: September 2011
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents