A Four Week, Open-Label Study of Azithromycin Ophthalmic Solution, 1% (P08641)

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: NCT01220258
Recruitment Status : Terminated
First Posted : October 13, 2010
Last Update Posted : December 16, 2013
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
One objective of this study is to determine the levels of markers of inflammation on the eyelid margin of subjects with blepharoconjunctivitis and compare them with those of healthy volunteers. Another objective is to determine in subjects with blepharoconjunctivitis the effect of azithromycin ophthalmic solution, 1 % on markers of inflammation of lid margins and conjunctivae and on signs and symptoms of blepharoconjunctivitis.

Condition or disease Intervention/treatment Phase
Posterior Blepharoconjunctivitis Drug: Azithromycin ophthalmic solution, 1% Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Center, Open-Label Study to Characterize Eyelid Margin Erythema, Markers of Clinical Inflammation and Levels of Inflammatory Mediators in the Lid Margins and Conjunctivae of Untreated Healthy Volunteers and Subjects Diagnosed With Posterior Blepharoconjunctivitis Following Dosing With Azithromycin Ophthalmic Solution, 1% for Four Weeks
Study Start Date : November 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Azithromycin ophthalmic solution, 1% Drug: Azithromycin ophthalmic solution, 1%
1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)

Primary Outcome Measures :
  1. Change from baseline of investigator-rated scores for eyelid margin erythema [ Time Frame: Week 4 ]

Secondary Outcome Measures :
  1. Change from baseline of investigator-rated scores of blepharoconjunctivitis signs [ Time Frame: Weeks 2, 4, 6, 8 ]
  2. Change from baseline of subject-rated scores of blepharoconjunctivitis symptoms [ Time Frame: Weeks 2, 4, 6, 8 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Have a current diagnosis of posterior blepharoconjunctivitis in both eyes

(except for healthy volunteers)

  • Have a Best Corrected Visual Acuity (BCVA), using corrective lenses if necessary, 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 had penetrating intraocular surgery in the past 90 days or require

penetrating intraocular surgery during the study

  • Unable to withhold the use of contact lenses within 3 days prior to Visit 1

during the study

  • Have been diagnosed with ongoing glaucoma
  • Have a serious medical condition which could 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): NCT01220258

United States, Texas
Baylor Eye Clinic, Alkek Eye Center of Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Chair: Reza Haque, MD, PhD Medical Monitor

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01220258     History of Changes
Other Study ID Numbers: P08641
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: December 16, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Conjunctival Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Anti-Bacterial Agents
Anti-Infective Agents