Phase 3
N=957
A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.
Acute Bacterial Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT00347932 ↗Enrolled (actual)
957
Serious AEs
0.2%
Results posted
Aug 2009
Primary outcome: Primary: Clinical Resolution of Baseline Bacterial Conjunctivitis — 90; 63 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ISV-403 (Drug); Vehicle (Drug)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Resolution of Baseline Bacterial Conjunctivitis |
168; 132 | — |
| PRIMARY Microbial Eradication of Baseline Bacterial Infection |
176; 137 | — |
| SECONDARY Clinical Resolution of Baseline Bacterial Conjunctivitis |
168; 132 | — |
| SECONDARY Microbial Eradication of Baseline Bacterial Infection |
176; 137 | — |
Summary
Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.
Eligibility Criteria
Inclusion Criteria
- Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
- Females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test.
Exclusion Criteria
- Pregnant or nursing females.
- Known hypersensitivity to fluoroquinolones or to any of the study ingredients.
- Use of any antibiotic within 72 hours of treatment.
- Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications.
- Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.
Data sourced from ClinicalTrials.gov (NCT00347932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.