Trial Outcomes & Findings for Comparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects (NCT NCT01808547)

Results Overview

Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is \> 50 cells, and no rescue medications.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

268 participants

Primary outcome timeframe

15 days

Results posted on

2021-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	ISV-303 0.075% bromfenac in DuraSite dosed BID	Vehicle DuraSite vehicle dosed BID
Overall Study STARTED	174	94
Overall Study Safety Population	170	85
Overall Study mITT Population	168	85
Overall Study COMPLETED	137	48
Overall Study NOT COMPLETED	37	46

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ISV-303 n=168 Participants 0.075% bromfenac in DuraSite dosed BID	Vehicle n=85 Participants DuraSite vehicle dosed BID	Total n=253 Participants Total of all reporting groups
Age, Continuous	69.6 years STANDARD_DEVIATION 8.90 • n=5 Participants	72.0 years STANDARD_DEVIATION 9.07 • n=7 Participants	70.4 years STANDARD_DEVIATION 9.01 • n=5 Participants
Age, Customized < 65 years	44 participants n=5 Participants	16 participants n=7 Participants	60 participants n=5 Participants
Age, Customized ≥ 65 years	124 participants n=5 Participants	69 participants n=7 Participants	193 participants n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	48 Participants n=7 Participants	153 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	37 Participants n=7 Participants	100 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 days

Population: Modified Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method.

Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is \> 50 cells, and no rescue medications.

Outcome measures

Outcome measures
Measure	ISV-303 n=168 Participants 0.075% bromfenac in DuraSite dosed BID	Vehicle n=85 Participants DuraSite vehicle dosed BID
Ocular Inflammation	64 participants	19 participants

Adverse Events

ISV-303

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Vehicle

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ISV-303 n=170 participants at risk 0.075% bromfenac in DuraSite dosed BID	Vehicle n=85 participants at risk DuraSite vehicle dosed BID
Gastrointestinal disorders Colitis	0.00% 0/170 • 29 days	1.2% 1/85 • 29 days
General disorders Chest pain	0.59% 1/170 • 29 days	0.00% 0/85 • 29 days

Other adverse events

Other adverse events
Measure	ISV-303 n=170 participants at risk 0.075% bromfenac in DuraSite dosed BID	Vehicle n=85 participants at risk DuraSite vehicle dosed BID
Eye disorders Ocular hypertension	10.0% 17/170 • 29 days	5.9% 5/85 • 29 days

Additional Information

Senior Manager, Clinical Sciences

InSite Vision

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER