Trial Outcomes & Findings for A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis. (NCT NCT00347932)

NCT ID: NCT00347932

Last Updated: 2015-03-24

Results Overview

The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 957 participants
• Primary outcome timeframe: Day 5 +/- 1 day
• Results posted on: 2015-03-24

Participant Flow

First subject enrolled 6/5/2006, last patient exited on 11/7/2007. This study was conducted at multiple sites in the US.

957 Subjects with bacterial conjunctivitis were randomized to receive besifloxacin ophthalmic suspension or its vehicle, 11 subjects were discontinued due to failure to meet enrollment criteria or used disallowed medications.

Participant milestones

Measure	ISV-403 Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.	Vehicle Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
Overall Study STARTED	475	482
Overall Study COMPLETED	444	430
Overall Study NOT COMPLETED	31	52

Reasons for withdrawal

Measure	ISV-403 Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.	Vehicle Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
Overall Study Adverse Event	4	5
Overall Study Lack of Efficacy	3	14
Overall Study Lost to Follow-up	10	9
Overall Study Withdrawal by Subject	10	16
Overall Study Did not meet inclusion criteria	4	8

Baseline Characteristics

A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.

Baseline characteristics by cohort

Measure	ISV-403 n=475 Participants Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.	Vehicle n=482 Participants Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.	Total n=957 Participants Total of all reporting groups
Age, Customized <2 years	21 participants n=5 Participants	20 participants n=7 Participants	41 participants n=5 Participants
Age, Customized 2 to 19 years	196 participants n=5 Participants	196 participants n=7 Participants	392 participants n=5 Participants
Age, Customized 20 to 59 years	212 participants n=5 Participants	226 participants n=7 Participants	438 participants n=5 Participants
Age, Customized >=60 years	46 participants n=5 Participants	40 participants n=7 Participants	86 participants n=5 Participants
Sex: Female, Male Female	302 Participants n=5 Participants	300 Participants n=7 Participants	602 Participants n=5 Participants
Sex: Female, Male Male	173 Participants n=5 Participants	182 Participants n=7 Participants	355 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	312 Participants n=5 Participants	312 Participants n=7 Participants	624 Participants n=5 Participants
Race/Ethnicity, Customized Asian	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	44 Participants n=5 Participants	46 Participants n=7 Participants	90 Participants n=5 Participants
Race/Ethnicity, Customized Other	109 Participants n=5 Participants	117 Participants n=7 Participants	226 Participants n=5 Participants
Region of Enrollment United States	475 participants n=5 Participants	482 participants n=7 Participants	957 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 5 +/- 1 day

Population: Modified intent to treat population, culture confirmed, as randomized

The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection

Outcome measures

Measure	ISV-403 n=199 Participants Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.	Vehicle n=191 Participants Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
Clinical Resolution of Baseline Bacterial Conjunctivitis	90 Participants	63 Participants

PRIMARY outcome

Timeframe: Day 5 +/- 1 day

Population: Modified Intent to treat population, culture confirmed, as randomized.

Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.

Outcome measures

Measure	ISV-403 n=199 Participants Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.	Vehicle n=191 Participants Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
Microbial Eradication of Baseline Bacterial Infection	182 Participants	114 Participants

SECONDARY outcome

Timeframe: Day 8 or 9

Population: Modified intent to treat population, culture confirmed, as randomized

The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection

Outcome measures

Measure	ISV-403 n=199 Participants Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.	Vehicle n=191 Participants Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
Clinical Resolution of Baseline Bacterial Conjunctivitis	168 Participants	132 Participants

SECONDARY outcome

Timeframe: Day 8 or 9

Population: Modified intent to treat population, culture confirmed, as randomized.

Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.

Outcome measures

Measure	ISV-403 n=199 Participants Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.	Vehicle n=191 Participants Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
Microbial Eradication of Baseline Bacterial Infection	176 Participants	137 Participants

Adverse Events

ISV-403

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Vehicle

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	ISV-403 n=741 participants at risk；n=442 participants at risk Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.	Vehicle n=760 participants at risk；n=432 participants at risk Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.23% 1/442 • Number of events 1 • 8 days Treatment emergent ocular adverse events occured in \< 5% of the patients	0.23% 1/432 • Number of events 1 • 8 days Treatment emergent ocular adverse events occured in \< 5% of the patients

Other adverse events

Adverse event data not reported

Additional Information

Timothy Comstock

Bausch & Lomb Incorporated

Phone: (585) 338-6631

Email: timothy.comstock@bausch.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor has 45 days to review materials and provide comments back to the investigator.
• Publication restrictions are in place

Restriction type: OTHER