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
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
Eyelid Diseases
Eye Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014