Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/30/2013 |
| Start Date: | May 2011 |
| End Date: | July 2014 |
| Contact: | Dan Donatello |
| Email: | Dan.Donatello@bausch.com |
| Phone: | (585) 338-6204 |
Evaluation of the Safety and Efficacy of Topical Besifloxacin Ophthalmic Suspension, 0.6% Compared With Gatifloxacin, 0.3% Ophthalmic Solution for the Treatment of Presumed Bacterial Conjunctivitis in Subjects From Birth to 31 Days of Age
The objective of this study is to evaluate the safety and efficacy of Besivance
(besifloxacin 0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution
when administered three times daily (TID) for seven days to neonatal subjects who are 31
days or younger on the day of randomization (Visit 1).
Inclusion Criteria:
- Subjects who have a clinical diagnosis of acute bacterial conjunctivitis and exhibit
conjunctival discharge and redness in at least one eye. A minimum score of 1 should
be present for discharge and a minimum score of 1 for conjunctival hyperemia in the
same eye.
Exclusion Criteria:
- Subjects with conjunctivitis signs and/or symptoms suggestive of fungal, protozoal,
or viral etiology in either eye.
- Subjects who require or are expected to require (other than study medication) use of
any topical ocular medication in either eye, or systemic medications during the
course of the study or prior to Day 1 specified in the protocol as ineligible.
- Subjects with any abnormality of the ocular anatomy or ocular disease/disorder
specified in the protocol as ineligible.
- Subjects with systemic disease/disorder specified in the protocol as ineligible.
- Subjects who have a known or suspected poor tolerance, sensitivity, or allergy to the
study medications or any of their components.
- Subjects who have a condition or are in a situation which in the investigator's
opinion may impact their safety or would negatively affect the conduct or outcome of
the study.
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