Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

November 12, 2009
September 20, 2011
October 2009
March 2010   (final data collection date for primary outcome measure)
Tear Break-Up Time (TBUT) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01014078 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dry Eye Disease
  • 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)
  • 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)
  • Experimental: Azithromycin Ophthalmic Solution, 1%
    Intervention: Drug: Azithromycin Ophthalmic Solution, 1%
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01014078
041-116, P08646
Not Provided
Mike Schiewe, Associate Director, Inspire
Merck Sharp & Dohme Corp.
Not Provided
Study Chair: Reza Haque, MD, PhD Medical Monitor
Merck Sharp & Dohme Corp.
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP