Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)

• ClinicalTrials.gov Identifier: NCT00105534
• Recruitment Status: Completed
• First Posted: March 16, 2005
• Results First Posted: October 27, 2011
• Last Update Posted: November 21, 2013
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Tracking Information

• First Submitted Date: March 15, 2005
• First Posted Date: March 16, 2005
• Results First Submitted Date: August 1, 2011
• Results First Posted Date: October 27, 2011
• Last Update Posted Date: November 21, 2013
• Study Start Date: July 2004
• Actual Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 20, 2011)

Participants Who Achieved Clinical Resolution [ Time Frame: Visit 3 (Days 6-7) ]

Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection.

Original Primary Outcome Measures (submitted: June 23, 2005)

• Clinical assessments of ocular discharge
• Bacteriological cultures

Current Secondary Outcome Measures (submitted: September 20, 2011)

Participants Who Achieved Bacteriological Eradication [ Time Frame: Visit 3 (Day 6-7) ]

Bacterial eradication is defined as the eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).

Original Secondary Outcome Measures (submitted: June 23, 2005)

• Adverse events
• Visual acuity
• Biomicroscopy
• Ophthalmoscopy

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)
• Official Title: A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0 % AzaSite Compared to Vehicle in the Treatment of Bacterial Conjunctivitis
• Brief Summary: The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either 1.0 % AzaSite or Vehicle. Three visits will be required for this study.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Bacterial Conjunctivitis

Intervention

• Drug: AzaSite

  1.0% AzaSite contains 1.0% azithromycin, sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. AzaSite was prescribed as a single topical drop to the infected

  eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.

• Other: Vehicle
  Vehicle contains sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. Vehicle was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.

Study Arms

• Experimental: AzaSite
  Intervention: Drug: AzaSite
• Sham Comparator: Vehicle
  Intervention: Other: Vehicle

• Publications *: Abelson MB, Heller W, Shapiro AM, Si E, Hsu P, Bowman LM; AzaSite Clinical Study Group. Clinical cure of bacterial conjunctivitis with azithromycin 1%: vehicle-controlled, double-masked clinical trial. Am J Ophthalmol. 2008 Jun;145(6):959-65. doi: 10.1016/j.ajo.2008.01.019. Epub 2008 Mar 28.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 20, 2011): 685
• Original Enrollment (submitted: June 23, 2005): 600
• Actual Study Completion Date: January 2006
• Actual Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Male or female subject, of any race, who is at least 1 year of age.
• Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent or purulent conjunctival discharge (crusty or sticky eyelids, globular and yellow discharge) and redness in at least one eye.
• The symptoms of bacterial conjunctivitis must be present for 3 days (approximately 72 hours) or less.
• Must be willing to discontinue contact lens wear for the duration of the study.

Exclusion Criteria:

• Any uncontrolled, systemic, debilitating disease.
• Use of topical ophthalmic solutions including tear substitutes within 2 hours before and during the study.
• Use of any topical ophthalmic anti-inflammatory agents within 48 hours before and during the study.
• Any active upper respiratory tract infection.
• Pregnant or nursing females.
• Use of any antibiotic (topical or systemic) within 72 hours of enrollment

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00105534
• Other Study ID Numbers: P08635; C-01-401-003
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Merck Sharp & Dohme LLC
• Original Responsible Party: Not Provided
• Current Study Sponsor: Merck Sharp & Dohme LLC
• Original Study Sponsor: Sun Pharmaceutical Industries Limited
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Merck Sharp & Dohme LLC
• Verification Date: October 2013