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

Bacterial Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01330355
• Other study ID #: 646
• Status: Terminated
• Phase: Phase 3
• First received: April 5, 2011
• Last updated: September 2, 2014
• Start date: May 2011
• Est. completion date: October 2013

Study information

• Verified date: August 2014
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: October 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 31 Days

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Bacterial Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Bacterial

Intervention

Drug:
• Besivance
Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days
• Gatifloxacin
Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days

Locations

Country	Name	City	State
United States	Bausch & Lomb Incorporated	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Resolution	Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.	Visit 5 (Day 8+1)	No
Secondary	Clinical Resolution	Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.	Visit 3 (Day 3)	No
Secondary	Microbial Eradication	Eradication defined as the absence of all accepted ocular bacterial species (as measured on the ordinal scale) that were present at or above threshold at baseline	Visit 5 (Day 8+1)	No
Secondary	Microbial Outcome	Microbial outcome for the following groups of accepted ocular bacterial species that were present at or above threshold at baseline: over all bacterial species; over all and individual gram-positive bacterial species; over all and individual gram-negative bacterial species	Visit 3 (Day 3) and Visit 5 (Day 8+1)	No