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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01014078
First received: November 12, 2009
Last updated: September 20, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Dry Eye Disease
Drug: Azithromycin Ophthalmic Solution, 1%
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Tear Break-Up Time (TBUT) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 112
Study Start Date: October 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014078

Locations
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.
Investigators
Study Chair: Reza Haque, MD, PhD Medical Monitor
  More Information

No publications provided

Responsible Party: Mike Schiewe, Associate Director, Inspire
ClinicalTrials.gov Identifier: NCT01014078     History of Changes
Other Study ID Numbers: 041-116, P08646
Study First Received: November 12, 2009
Last Updated: September 20, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014