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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00894530
First received: May 5, 2009
Last updated: October 29, 2013
Last verified: October 2013
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Signs and symptoms of Blepharitis [ Time Frame: One week, two weeks, three weeks, four weeks, six weeks, eight weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00894530

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00894530     History of Changes
Other Study ID Numbers: P08638, 044-102
Study First Received: May 5, 2009
Last Updated: October 29, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014