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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

December 21, 2010
October 29, 2013
December 2010
June 2011   (final data collection date for primary outcome measure)
Resolution of clinical signs of blepharitis [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01269658 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636)
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

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.

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%
    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)
  • 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)
  • Experimental: Azithromycin ophthalmic solution, 1%
    Intervention: Drug: Azithromycin ophthalmic solution, 1%
  • Placebo Comparator: Vehicle
    Intervention: Drug: Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
14 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01269658
P08636, P08636
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Chair: Charles Johnson, MBChB Chief Medical Officer
Merck Sharp & Dohme Corp.
October 2013

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