Trial Outcomes & Findings for Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis (NCT NCT00622908)

NCT ID: NCT00622908

Last Updated: 2015-03-24

Results Overview

Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 270 participants
• Primary outcome timeframe: Visit 3 - day 8 or 9
• Results posted on: 2015-03-24

Participant Flow

Study was started on 12/28/04 and last patient last visit was 6/7/05. This study took place at 35 centers in the US.

270 subjects were enrolled, 269 were randomized(1 subject refused culture), 118 of which had bacteriologically confirmed acute bacterial conjunctivitis at baseline.

Participant milestones

Measure	ISV-403 0.6% ISV-403	Vehicle Vehicle of ISV-403
Overall Study STARTED	137	132
Overall Study COMPLETED	134	122
Overall Study NOT COMPLETED	3	10

Reasons for withdrawal

Measure	ISV-403 0.6% ISV-403	Vehicle Vehicle of ISV-403
Overall Study Protocol Violation	1	0
Overall Study Adverse Event	0	1
Overall Study Lack of Efficacy	1	7
Overall Study Lost to Follow-up	1	0
Overall Study Refusal	0	1
Overall Study Termination by study sponser	0	1

Baseline Characteristics

Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis

Baseline characteristics by cohort

Measure	ISV-403 n=137 Participants 0.6% ISV-403	Vehicle n=132 Participants Vehicle of ISV-403	Total n=269 Participants Total of all reporting groups
Age, Continuous	33.3 years STANDARD_DEVIATION 22.3 • n=5 Participants	35.1 years STANDARD_DEVIATION 22.4 • n=7 Participants	34.2 years STANDARD_DEVIATION 22.3 • n=5 Participants
Age, Customized < 2 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Customized 2 to 19 Years	44 Participants n=5 Participants	37 Participants n=7 Participants	81 Participants n=5 Participants
Age, Customized 20 to 59 Years	71 Participants n=5 Participants	71 Participants n=7 Participants	142 Participants n=5 Participants
Age, Customized >/=60 Years	20 Participants n=5 Participants	23 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants	76 Participants n=7 Participants	162 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	56 Participants n=7 Participants	107 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	116 participants n=5 Participants	106 participants n=7 Participants	222 participants n=5 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	6 participants n=5 Participants	11 participants n=7 Participants	17 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	12 participants n=5 Participants	8 participants n=7 Participants	20 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 3 - day 8 or 9

Population: Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.

Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.

Outcome measures

Measure	ISV-403 n=60 Participants 0.6% ISV-403	Vehicle n=56 Participants Vehicle of ISV-403
Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9)	37 Participants	20 Participants

PRIMARY outcome

Timeframe: Visit 3 - Day 8 or day 9

Population: Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.

Bacterial species eradication of baseline bacterial infection

Outcome measures

Measure	ISV-403 n=60 Participants 0.6% ISV-403	Vehicle n=55 Participants Vehicle of ISV-403
Eradication of Baseline Pathogens (Day 8 or 9)	54 Participants	38 Participants

SECONDARY outcome

Timeframe: Visit 2 - Day 4 (+/- 1 day)

Population: Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.

The absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.

Outcome measures

Measure	ISV-403 n=60 Participants 0.6% ISV-403	Vehicle n=56 Participants Vehicle of ISV-403
Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day)	14 Participants	8 Participants

SECONDARY outcome

Timeframe: Visit 2 - Day 4 (+/- 1 day)

Population: Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.

Bacterial species eradication of baseline bacterial infection

Outcome measures

Measure	ISV-403 n=60 Participants 0.6% ISV-403	Vehicle n=54 Participants Vehicle of ISV-403
Eradication of Baseline Pathogens Day 4 (+/- 1 Day)	54 Participants	28 Participants

Adverse Events

ISV-403

Serious events: 1 serious events

Other events: 45 other events

Deaths: 0 deaths

Vehicle

Serious events: 1 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Measure	ISV-403 n=137 participants at risk 0.6% ISV-403	Vehicle n=132 participants at risk Vehicle of ISV-403
Nervous system disorders Loss of Consciousness	0.73% 1/137 • Number of events 1 • Treated period was 5 days	0.76% 1/132 • Number of events 1 • Treated period was 5 days

Other adverse events

Measure	ISV-403 n=137 participants at risk 0.6% ISV-403	Vehicle n=132 participants at risk Vehicle of ISV-403
Eye disorders Eye Pain	11.7% 16/137 • Number of events 24 • Treated period was 5 days	6.1% 8/132 • Number of events 24 • Treated period was 5 days
Eye disorders Blurred Vision	10.9% 15/137 • Number of events 28 • Treated period was 5 days	9.8% 13/132 • Number of events 28 • Treated period was 5 days
Eye disorders Eye Irritation	8.0% 11/137 • Number of events 27 • Treated period was 5 days	12.1% 16/132 • Number of events 27 • Treated period was 5 days
Eye disorders Eye Pruritis	2.2% 3/137 • Number of events 12 • Treated period was 5 days	6.8% 9/132 • Number of events 12 • Treated period was 5 days

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