Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial Conjunctivitis
Primary Purpose
Bacterial Conjunctivitis
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension
AL-15469A 0.5%
AL-6515 0.3%
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- Male and female patients of any race
- 5 years of age and older at the time of the Day 1 visit
- with a primary clinical diagnosis of bacterial conjunctivitis.
Exclusion Criteria:
- Onset of bacterial conjunctivitis (signs and symptoms) more than 4 days
- Presence of punctal plug or punctal occlusion
- Visual Acuity worse than 20/80
- Upper respiratory infection
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
AL-15469A 0.5% and AL-65150.3% Ophthalmic Suspension
AL-15469A 0.5%
AL-6515 0.3%
Vehicle
Arm Description
Outcomes
Primary Outcome Measures
Sustained Clinical Cure rate
End of therapy Clinical Cure rate
Secondary Outcome Measures
Sustained bulbar conjunctival injection
Microbiological Success
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01238783
Brief Title
Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Withdrawn
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess safety and efficacy of AL-15469A 0.5% /AL-6515 0.3% Ophthalmic Suspension for 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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AL-15469A 0.5% and AL-65150.3% Ophthalmic Suspension
Arm Type
Experimental
Arm Title
AL-15469A 0.5%
Arm Type
Experimental
Arm Title
AL-6515 0.3%
Arm Type
Experimental
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension
Intervention Description
Topical ocular dosed 3 times per day for 3 days
Intervention Type
Drug
Intervention Name(s)
AL-15469A 0.5%
Intervention Description
Topical ocular dosed 3 times per day for 3 days
Intervention Type
Drug
Intervention Name(s)
AL-6515 0.3%
Intervention Description
Topical ocular dosed 3 times per day for 3 days
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Topical ocular dosed 3 times per day for 3 days
Primary Outcome Measure Information:
Title
Sustained Clinical Cure rate
Time Frame
Day 3
Title
End of therapy Clinical Cure rate
Time Frame
Day 4
Secondary Outcome Measure Information:
Title
Sustained bulbar conjunctival injection
Time Frame
Day 3
Title
Microbiological Success
Time Frame
Day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients of any race
5 years of age and older at the time of the Day 1 visit
with a primary clinical diagnosis of bacterial conjunctivitis.
Exclusion Criteria:
Onset of bacterial conjunctivitis (signs and symptoms) more than 4 days
Presence of punctal plug or punctal occlusion
Visual Acuity worse than 20/80
Upper respiratory infection
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial Conjunctivitis
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