Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)

• ClinicalTrials.gov Identifier: NCT00105469
• Recruitment Status: Completed
• First Posted: March 15, 2005
• Results First Posted: October 27, 2011
• Last Update Posted: December 16, 2013
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by: Merck Sharp & Dohme LLC

Tracking Information

• First Submitted Date: March 14, 2005
• First Posted Date: March 15, 2005
• Results First Submitted Date: August 1, 2011
• Results First Posted Date: October 27, 2011
• Last Update Posted Date: December 16, 2013
• Study Start Date: July 2004
• Actual Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)

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

Number of Participants Who Achieved Clinical Resolution at Visit 3 [ Time Frame: Visit 3 (Day 6) ]

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)

Number of Participants Who Achieved Bacterial Eradication at Visit 3 [ Time Frame: Visit 3 (Day 6) ]

Bacterial eradication is defined as 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 Tobramycin for Bacterial Conjunctivitis (C-01-401-004)
• Official Title: A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0% AzaSite Compared to 0.3% Tobramycin Ophthalmic Solution 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 tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required for the study.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Bacterial Conjunctivitis

Intervention

• Drug: AzaSite
  AzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5.
• Drug: Tobramycin
  Tobramycin ophthalmic solution; one topical drop to the infected eye or eyes four times daily at 4 to 6 hour intervals (first dose in the morning between 7 and 10am) for 5 days.

Study Arms

• Experimental: AzaSite
  1.0% azithromycin in DuraSite
  Intervention: Drug: AzaSite
• Active Comparator: Tobramycin
  0.3% tobramycin
  Intervention: Drug: Tobramycin

• Publications *: Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9. doi: 10.1167/iovs.06-1413.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 20, 2011): 743
• Original Enrollment (submitted: June 23, 2005): 800
• Actual Study Completion Date: October 2005
• Actual Primary Completion Date: October 2005 (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 disease or 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 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: 1 Year 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: NCT00105469
• Other Study ID Numbers: P08633; C-01-401-004
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
• 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: November 2013