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
Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5%
Moxifloxacin hydrochloride ophthalmic solution 0.5% as base
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Conjunctivitis
Eligibility Criteria
Inclusion Criteria: signs and symptoms of bacterial conjunctivitis Other protocol-defined inclusion criteria may apply Exclusion Criteria: under 1 mo. age Other protocol-defined exclusion criteria may apply
Sites / Locations
- Contact Alcon for Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Moxifloxacin
VIGAMOX
Arm Description
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
NCT00332293
Brief Title
AL-15469A for the Treatment of Bacterial Conjunctivitis
Official Title
An Evaluation of the Safety and Efficacy of Moxifloxacin AF Ophthalmic Solution 0.5% for the Treatment of Bacterial Conjunctivitis in India
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
695 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moxifloxacin
Arm Type
Experimental
Arm Title
VIGAMOX
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5%
Intervention Description
1 drop into the conjunctival sac of both eyes 3 times a day for 3 days
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin hydrochloride ophthalmic solution 0.5% as base
Other Intervention Name(s)
VIGAMOX
Intervention Description
1 drop into the conjunctival sac of both eyes 3 times a day for 3 days
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 and symptoms of bacterial conjunctivitis
Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
under 1 mo. age
Other protocol-defined exclusion criteria may apply
Facility Information:
Facility Name
Contact Alcon for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21681652
Citation
Tauber S, Cupp G, Garber R, Bartell J, Vohra F, Stroman D. Microbiological efficacy of a new ophthalmic formulation of moxifloxacin dosed twice-daily for bacterial conjunctivitis. Adv Ther. 2011 Jul;28(7):566-74. doi: 10.1007/s12325-011-0037-x. Epub 2011 Jun 14.
Results Reference
result
Learn more about this trial
AL-15469A for the Treatment of Bacterial Conjunctivitis
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