A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01269658
First received: December 21, 2010
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus vehicle over a four-week treatment period in treating the signs and symptoms of subjects with blepharitis and to evaluate the clinical course of the condition under study.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-Center, Double-Masked, Vehicle-Controlled, Parallel-Group, Safety and Efficacy Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle for Four Weeks in Subjects With Blepharitis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Resolution of clinical signs of blepharitis [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first clinical resolution [ Time Frame: Days 7, 14, 21, 28, 42, 56, 70, and 84 ] [ Designated as safety issue: No ]
  • Mean and change from baseline for clinical signs of blepharitis [ Time Frame: Days 7, 14, 21, 28, 42, 56, 70, and 84 ] [ Designated as safety issue: No ]
  • Mean and change from end of dosing for clinical signs of blepharitis [ Time Frame: Days 42, 56, 70, and 84 ] [ Designated as safety issue: No ]
  • Response to the Blepharitis Symptoms Questionnaire (BSQ) [ Time Frame: Days 1, 7, 14, 21, 28, 42, 56, 70, and 84 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: December 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Placebo Comparator: Vehicle Drug: Vehicle
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)

  Eligibility

Ages Eligible for Study:   14 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a current diagnosis of blepharitis
  • Have a best corrected visual acuity (BCVA), using corrective lenses if

necessary, in both eyes of at least +0.7

  • If female, are non-pregnant or non-lactating

Exclusion Criteria:

  • Have a concurrent acute hordeolum (stye) or chalazion
  • Have inflammation of the ocular surface
  • Have used artificial tears within 48 hours prior to Visit 1 or anticipate

using during the study

  • Have had ocular surgery in the past 90 days or will require it during the

study

  • 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 been diagnosed with ongoing glaucoma
  • Unable to withhold the use of ocular cosmetic products within 48 hours

prior to Visit 1 and throughout the study

  • 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: NCT01269658

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Charles Johnson, MBChB Chief Medical Officer
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01269658     History of Changes
Other Study ID Numbers: P08636, P08636
Study First Received: December 21, 2010
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 20, 2014