Status:

COMPLETED

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

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Blepharitis

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2010

Estimated Enrollment :

313 Patients enrolled

Trial Details

Trial ID

NCT00892970

Start Date

April 1 2009

End Date

January 1 2010

Last Update

September 26 2011

Active Locations (33)

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Page 1 of 9 (33 locations)

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