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Sponsored by: |
Bausch & Lomb, Inc. |
---|---|
Information provided by: | Bausch & Lomb, Inc. |
ClinicalTrials.gov Identifier: | NCT00622908 |
To evaluate the clinical and microbial efficacy of ISV-403 administered three times a day for 5 days compared to vehicle three times a day for 5 days in the treatment of bacterial conjunctivitis
Condition | Intervention | Phase |
---|---|---|
Bacterial Conjunctivitis |
Drug: ISV-403 Other: vehicle |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vehicle in the Treatment of Bacterial Conjunctivitis |
Enrollment: | 270 |
Study Start Date: | December 2004 |
Study Completion Date: | June 2005 |
Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: ISV-403
0.6% TID, 5 days
|
2: Placebo Comparator |
Other: vehicle
TID, 5 days
|
Ages Eligible for Study: | 1 Year and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Bausch & Lomb, Inc. ( Tim Comstock ) |
Study ID Numbers: | 373 |
Study First Received: | February 14, 2008 |
Last Updated: | February 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00622908 |
Health Authority: | United States: Food and Drug Administration |
Bacterial Infections Eye Infections, Bacterial Conjunctivitis, Bacterial Eye Diseases |
Eye Infections Conjunctivitis Conjunctival Diseases |
Infection |