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Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis

Information source: Bausch & Lomb Incorporated
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Conjunctivitis

Intervention: Besivance (Drug); Gatifloxacin (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Bausch & Lomb Incorporated

Official(s) and/or principal investigator(s):
Johnson Varughese, Study Director, Affiliation: Valeant/Bausch & Lomb

Summary

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).

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Clinical Resolution

Secondary outcome:

Clinical Resolution

Microbial Eradication

Microbial Outcome

Eligibility

Minimum age: N/A. Maximum age: 31 Days. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Bausch & Lomb Incorporated, Bridgewater, New Jersey 08807, United States
Additional Information

Starting date: May 2011
Last updated: September 2, 2014

Page last updated: August 23, 2015

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