Bacterial Conjunctivitis Clinical Trial
Official title:
AL-15469A for the Treatment of Bacterial Conjunctivitis
NCT number | NCT00331916 |
Other study ID # | C-04-38 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | May 30, 2006 |
Last updated | September 25, 2009 |
Start date | November 2005 |
Verified date | September 2009 |
Source | Alcon Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of the study is to determine whether AL-15469A is safe and effective in the treatment of bacterial conjunctivitis.
Status | Completed |
Enrollment | 600 |
Est. completion date | |
Est. primary completion date | May 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month and older |
Eligibility |
Inclusion Criteria: - Signs & Symptoms of conjunctivitis Exclusion Criteria: - Under 1 mo. age |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | US | Fort Worth | Texas |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical cure and microbiological success | |||
Secondary | Individual signs and symptoms of bacterial conjunctivitis at each visit |
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