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The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Four-Week Treatment Period (P08638)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00894530
First Posted: May 7, 2009
Last Update Posted: November 21, 2013
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus placebo over a four-week treatment period.

Condition Intervention Phase
Blepharitis Drug: Azithromycin ophthalmic solution, 1% Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Eyelid margin erythema [ Time Frame: Four weeks ]

Secondary Outcome Measures:
  • Signs and symptoms of Blepharitis [ Time Frame: One week, two weeks, three weeks, four weeks, six weeks, eight weeks ]

Enrollment: 314
Study Start Date: May 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Azithromycin ophthalmic solution, 1%
One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 26 days
Placebo Comparator: 2 Drug: Placebo
One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 26 days

  Eligibility

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:   No
Criteria

Inclusion Criteria:

  • Have best corrected visual acuity in both eyes of at least +0.7 or better
  • If female, are non-pregnant or non-lactating
  • Have a current diagnosis of blepharitis in one or both eyes

Exclusion Criteria:

  • Have lid structural abnormalities
  • Have suspected ocular fungal or viral infection
  • Have practiced warm compress therapy within 14 days prior to Visit 2
  • Unable to withhold the use of contact lenses during the treatment or follow-up periods
  • Unable to withhold the use of ocular cosmetic products within 24 hours prior to study visits
  • Have had penetrating intraocular surgery within 90 days prior to Visit 2
  • Have had ocular surface surgery within the past year prior to Visit 2
  • Have a serious medical condition which could confound study assessments
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00894530


  Show 26 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Reza Haque, MD,PhD Medical Monitor, Inspire
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00894530     History of Changes
Other Study ID Numbers: P08638
044-102
First Submitted: May 5, 2009
First Posted: May 7, 2009
Last Update Posted: November 21, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Blepharitis
Eyelid Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents