Trial Outcomes & Findings for Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery (NCT NCT00704418)

Results Overview

Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=\>50 cells (intense)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

156 participants

Primary outcome timeframe

Day 15

Results posted on

2013-01-18

Participant Flow

This study was conducted at 19 sites, first participant entered the study 06/03/2008 and last participant completed the study 08/29/2008.

A total of 156 participants were randomized to investigational product and were included in the Intent-to-Treat (ITT) population; 78 were randomized to the bromfenac ophthalmic solution treatment group and 78 were randomized to the placebo treatment group.

Participant milestones

Participant milestones
Measure	Bromfenac Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily	Placebo Placebo, dosed 1 drop daily
Overall Study STARTED	78	78
Overall Study COMPLETED	73	72
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Bromfenac Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily	Placebo Placebo, dosed 1 drop daily
Overall Study Withdrawal by Subject	2	0
Overall Study Over-enrolled/surgery postponed	3	6

Baseline Characteristics

Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bromfenac n=78 Participants Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily	Placebo n=78 Participants Placebo, dosed 1 drop daily	Total n=156 Participants Total of all reporting groups
Age Continuous	68.7 years n=5 Participants	68.0 years n=7 Participants	68.4 years n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	48 Participants n=7 Participants	93 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	30 Participants n=7 Participants	63 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 15

Population: Last Observation Carried Forward Analysis(LOCF), ITT Population

Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=\>50 cells (intense)

Outcome measures

Outcome measures
Measure	Bromfenac n=78 Participants Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily	Placebo n=78 Participants Placebo, dosed 1 drop daily
Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero	36 participants	23 participants

SECONDARY outcome

Timeframe: Day 1

Population: LOCF Analysis, ITT Population

Participant description of being pain free (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses

Outcome measures

Outcome measures
Measure	Bromfenac n=78 Participants Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily	Placebo n=77 Participants Placebo, dosed 1 drop daily
Number of Participants That Are Pain Free	65 participants	40 participants

Adverse Events

Bromfenac

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bromfenac n=73 participants at risk Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily	Placebo n=73 participants at risk Placebo, dosed 1 drop daily
Eye disorders Corneal oedema	0.00% 0/73 • 14 days	5.5% 4/73 • Number of events 5 • 14 days
Eye disorders Eye Pain	2.7% 2/73 • Number of events 2 • 14 days	6.8% 5/73 • Number of events 5 • 14 days
Eye disorders Eye Inflammation	5.5% 4/73 • Number of events 5 • 14 days	13.7% 10/73 • Number of events 12 • 14 days

Additional Information

Tim McNamara, Vice President, Clinical Research & Medical Affairs

ISTA Pharmaceuticals, Inc.

Phone: 949-788-6000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The disclosure restriction on the PI is that the PI will provide to the sponsor a copy of proposed publication information for review, comment and approval following completion of the study and at least sixty (60) days prior to submission of the publication. If sponsor requests in writing, the PI will withhold publication until written permission is given by sponsor.
Publication restrictions are in place

Restriction type: OTHER