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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00894530
First received: May 5, 2009
Last updated: October 29, 2013
Last verified: October 2013

May 5, 2009
October 29, 2013
May 2009
December 2009   (final data collection date for primary outcome measure)
Eyelid margin erythema [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00894530 on ClinicalTrials.gov Archive Site
Signs and symptoms of Blepharitis [ Time Frame: One week, two weeks, three weeks, four weeks, six weeks, eight weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Four-Week Treatment Period (P08638)
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Blepharitis
  • 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
  • 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
  • Experimental: 1
    Intervention: Drug: Azithromycin ophthalmic solution, 1%
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
314
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00894530
P08638, 044-102
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Chair: Reza Haque, MD,PhD Medical Monitor, Inspire
Merck Sharp & Dohme Corp.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP