ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00892970
Recruitment Status : Completed
First Posted : May 5, 2009
Last Update Posted : September 26, 2011
Sponsor:
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% versus placebo over a two-week treatment period.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 313 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arm Intervention/treatment
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 12 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 12 days



Primary Outcome Measures :
  1. Eyelid margin erythema [ Time Frame: Two weeks ]

Secondary Outcome Measures :
  1. Signs and symptoms of Blepharitis [ Time Frame: One week, two weeks, three weeks, four 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.


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

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): NCT00892970


  Show 33 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Reza Haque, MD, PhD Medical Monitor, Inspire

Responsible Party: Mike Schiewe, Inspire
ClinicalTrials.gov Identifier: NCT00892970     History of Changes
Other Study ID Numbers: 044-101
P08639
First Posted: May 5, 2009    Key Record Dates
Last Update Posted: September 26, 2011
Last Verified: September 2011

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