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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01330355
Other study ID # 646
Secondary ID
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


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
See also
  Status Clinical Trial Phase
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Completed NCT00972777 - Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis Phase 2/Phase 3
Completed NCT00798577 - Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment Phase 4
Completed NCT00759148 - Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis Phase 3
Completed NCT00331916 - AL-15469A for the Treatment of Bacterial Conjunctivitis Phase 3
Completed NCT02432807 - Safety and Efficacy of Vancomycin Ophthalmic Ointment in Patients With Moderate to Severe Bacterial Conjunctivitis Phase 3
Completed NCT01573910 - An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% ((VIGAMOX®) Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients Phase 3
Completed NCT00332293 - AL-15469A for the Treatment of Bacterial Conjunctivitis Phase 3
Completed NCT03004924 - Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo Phase 3
Completed NCT02980523 - Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin) Phase 2
Completed NCT01877694 - Efficacy and Safety of Auriclosene (NVC-422) in the Treatment of Bacterial Conjunctivitis Phase 2
Completed NCT01175590 - Safety of Besivanceā„¢ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle Phase 3
Completed NCT00464438 - A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis Phase 4
Completed NCT00312338 - Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora Phase 4
Recruiting NCT03235141 - Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers Phase 1
Completed NCT00105469 - Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004) Phase 3
Completed NCT00105534 - Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003) Phase 3
Recruiting NCT06363292 - Study to Evaluate the Safety and Tolerability of PRO-231 Ophthalmic Solution Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects. Phase 1
Withdrawn NCT01238783 - Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial Conjunctivitis Phase 2
Terminated NCT01740388 - Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis Phase 3