Bacterial Conjunctivitis Clinical Trial
Official title:
An Evaluation of the Safety and Efficacy of Moxifloxacin AF Ophthalmic Solution 0.5% for the Treatment of Bacterial Conjunctivitis in India
Verified date | March 2012 |
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 | 695 |
Est. completion date | December 2006 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Contact Alcon for Trial Locations | Fort Worth | Texas |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
United States,
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. — View Citation
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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