Back to resultsAL-15469A for the Treatment of Bacterial Conjunctivitis
Primary Purpose
Bacterial Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
quinolone
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Conjunctivitis
Eligibility Criteria
Inclusion Criteria: Signs & Symptoms of conjunctivitis Exclusion Criteria: Under 1 mo. age
Sites / Locations
- US
Outcomes
Primary Outcome Measures
Clinical cure and microbiological success
Secondary Outcome Measures
Individual signs and symptoms of bacterial conjunctivitis at each visit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00331916
Brief Title
AL-15469A for the Treatment of Bacterial Conjunctivitis
Official Title
AL-15469A for the Treatment of Bacterial Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to determine whether AL-15469A is safe and effective in the treatment of bacterial conjunctivitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
quinolone
Primary Outcome Measure Information:
Title
Clinical cure and microbiological success
Secondary Outcome Measure Information:
Title
Individual signs and symptoms of bacterial conjunctivitis at each visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signs & Symptoms of conjunctivitis
Exclusion Criteria:
Under 1 mo. age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stella Robertson, Ph.D.
Organizational Affiliation
Study Director
Official's Role
Study Director
Facility Information:
Facility Name
US
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
AL-15469A for the Treatment of Bacterial Conjunctivitis
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