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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00892970
Collaborator
(none)
313
Enrollment
33
Locations
2
Arms
9
Duration (Months)
9.5
Patients Per Site
1
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 two-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 :
313 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Jan 1, 2010
Actual Study Completion Date :
Jan 1, 2010

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 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

Outcome Measures

Primary Outcome Measures

  1. Eyelid margin erythema [Two weeks]

Secondary Outcome Measures

  1. Signs and symptoms of Blepharitis [One week, two weeks, three weeks, four 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 Jones Eye Institute Little Rock Arkansas United States 72205
2 Sall Medical Research Center Artesia California United States 90701
3 Milton Hom, OD Azusa California United States 91702
4 The Jules Stein Eye Institute UCLA Laser Refractive Center Los Angeles California United States 90095
5 North Valley Eye Medical Group Mission Hills California United States 91345
6 David Wirta, MD, Inc. Newport Beach California United States 92663
7 North Bay Eye Associates Petaluma California United States 94954
8 West Coast Eye Care San Diego California United States 92115-1754
9 Wolstan Eye Associates Torrence California United States 90505
10 Eye Center - A Medical and Surgical Group Hamden Connecticut United States 06518
11 Florida Eye Microsurgical Institute Boynton Beach Florida United States 33426
12 Eye Centers of Florida Fort Myers Florida United States 33901
13 NorthShore University HealthSystems Glenview Illinois United States 60025
14 Chicago Cornea Consultants Hoffman Estates Illinois United States 60169
15 Indiana University School of Medicine, Ophthalmology Dept. Indianapolis Indiana United States 46202
16 Eye Physicians and Surgeons, LLP Iowa City Iowa United States 52245
17 Koffler Vision Group Lexington Kentucky United States 40509
18 Wilmer Eye Institute, Johns Hopkins Hospital Baltimor Maryland United States 21287
19 Ophthalmic Consultants of Boston Boston Massachusetts United States 02114
20 Minnesota Eye Consultants Minneapolis Minnesota United States 55404
21 Ophthalmology Associates St. Louis Missouri United States 63131
22 Ophthalmology Consultants St. Louis Missouri United States 63131
23 Brar-Parekh Eye Associates West Paterson New Jersey United States 07424
24 South Shore Eye Care Wantagh New York United States 11793
25 Mundorf Eye Center Charlotte North Carolina United States 28204
26 TLC Laser Eye Center Greensboro North Carolina United States 27410
27 Cornerstone Eye Care High Point North Carolina United States 27262
28 Abrams Eye Center Cleveland Ohio United States 44115
29 Bucci Laser Vision Institute Wilkes-Barre Pennsylvania United States 18702
30 McCabe Vision Center Murfreesboro Tennessee United States 37129
31 Eye Clinic of Austin Austin Texas United States 78731
32 See Clearly Vision Group McLean Virginia United States 22101
33 Virginia Eye Consultants Norfolk Virginia United States 23502

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:
, ,
ClinicalTrials.gov Identifier:
NCT00892970
Other Study ID Numbers:
  • 044-101
  • P08639
First Posted:
May 5, 2009
Last Update Posted:
Sep 26, 2011
Last Verified:
Sep 1, 2011
Additional relevant MeSH terms:
Blepharitis
Azithromycin
Ophthalmic Solutions

Study Results

No Results Posted as of Sep 26, 2011