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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00894530
Collaborator
(none)
314
Enrollment
26
Locations
2
Arms
7
Duration (Months)
12.1
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Azithromycin ophthalmic solution, 1%
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
314 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date :
May 1, 2009
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures

  1. Eyelid margin erythema [Four weeks]

Secondary Outcome Measures

  1. Signs and symptoms of Blepharitis [One week, two weeks, three weeks, four weeks, six weeks, eight weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Schwartz Laser Eye Center Scottsdale Arizona United States 85260
2 McDonald Eye Associates Fayetteville Arkansas United States 72703
3 Sall Research Medical Center, Inc. Artesia California United States 90701
4 Sall Research Medical Center Artesia California United States 90701
5 United Medical Research Company Inglewood California United States 90301
6 North Valley Eye Medical Group Mission Hills California United States 91345
7 Coastal Vision Medical Group Newport Beach California United States 92660
8 West Coast Eye Care San Diego California United States 92115-1754
9 Hernando Eye Institute Brooksville Florida United States 34613
10 Center for Excellence in Eye Care Miami Florida United States 33176
11 Wohl Eye Center Bloomingdale Illinois United States 60108
12 Thomas John Vision Institute Tinley Park Illinois United States 60477
13 Grene Vision Group Wichita Kansas United States 67208
14 Taustine Eye Center Louisville Kentucky United States 40217
15 Eastern Maine Medical Center Bangor Maine United States 04401
16 Ophthalmology Associates St Louis Missouri United States 63131
17 Comprehensive Eye Care Ltd Washington Missouri United States 63090
18 David M. Ringel, DO, PA Sewell New Jersey United States 08080
19 Brar-Parekh Eye Associates West Paterson New Jersey United States 07424
20 Ophthalmic Consultants of Long Island Lynbrook New York United States 11563
21 Park Ophthalmology Durham North Carolina United States 27713
22 Ohio State University - College of Optometry Columbus Ohio United States 43210
23 Columbus Ophthalmology Associates Columbus Ohio United States 43213
24 Philadelphia Eye Associates Philadelphia Pennsylvania United States 19148
25 Total Eye Care, PA Memphis Tennessee United States 38119
26 Eye Clinics of South Texas San Antonio Texas United States 78209

Sponsors and Collaborators

  • Merck Sharp & Dohme LLC

Investigators

  • Study Chair: Reza Haque, MD,PhD, Medical Monitor, Inspire

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT00894530
Other Study ID Numbers:
  • P08638
  • 044-102
First Posted:
May 7, 2009
Last Update Posted:
Nov 21, 2013
Last Verified:
Oct 1, 2013
Additional relevant MeSH terms:
Blepharitis
Azithromycin
Ophthalmic Solutions

Study Results

No Results Posted as of Nov 21, 2013