Trial Outcomes & Findings for Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery (NCT NCT00703781)

Last Updated: 2015-03-24

Results Overview

Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 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

126 participants

Primary outcome timeframe

Day 15

Results posted on

2015-03-24

Participant Flow

Study start date was 06/10/2008 and last participant to exit the study was 09/02/2008. This study was conducted in 18 study centers.

A total of 126 subjects were randomized to investigational product and were included in the Intent-to-Treat (ITT) population; 63 were randomized to the bromfenac ophthalmic solution treatment group and 63 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	63	63
Overall Study COMPLETED	61	61
Overall Study NOT COMPLETED	2	2

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	1	2
Overall Study Cancelled surgery	1	0

Baseline Characteristics

Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bromfenac n=63 Participants Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily	Placebo n=63 Participants Placebo, Dosed 1 Drop Daily	Total n=126 Participants Total of all reporting groups
Age, Continuous	67.1 years FULL_RANGE 10.8 • n=5 Participants	68.6 years FULL_RANGE 8.6 • n=7 Participants	67.9 years FULL_RANGE 9.8 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	38 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 15

Population: Last Observation Carried Forward Analysis (LOCF). Intent to treat population (ITT)

Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 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=63 Participants Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily	Placebo n=63 Participants Placebo, Dosed 1 Drop Daily
Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero	28 Participants	20 Participants

SECONDARY outcome

Timeframe: Day 1

Population: LOCF Analysis, ITT Population

Participant description of being pain free taken from patient questionnaire with multiple possible responses (None, Mild, Moderate, Severe) within one hour of instilling eye drop

Outcome measures

Outcome measures
Measure	Bromfenac n=63 Participants Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily	Placebo n=63 Participants Placebo, Dosed 1 Drop Daily
Number of Participants That Are Pain Free	51 Participants	46 Participants

Adverse Events

Bromfenac

Serious events: 2 serious events

Other events: 46 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bromfenac n=61 participants at risk Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily	Placebo n=61 participants at risk Placebo, Dosed 1 Drop Daily
Gastrointestinal disorders Nausea and Vomiting Symptoms	1.6% 1/61 • Number of events 1 • 2 weeks	0.00% 0/61 • 2 weeks
Renal and urinary disorders Renal Failure	1.6% 1/61 • Number of events 1 • 2 weeks	0.00% 0/61 • 2 weeks

Other adverse events

Other adverse events
Measure	Bromfenac n=61 participants at risk Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily	Placebo n=61 participants at risk Placebo, Dosed 1 Drop Daily
Eye disorders Corneal Edema	6.6% 4/61 • Number of events 4 • 2 weeks	3.3% 2/61 • Number of events 2 • 2 weeks
Eye disorders Lacrimation Increased	4.9% 3/61 • Number of events 4 • 2 weeks	9.8% 6/61 • Number of events 7 • 2 weeks
Eye disorders Eye Pain	8.2% 5/61 • Number of events 6 • 2 weeks	11.5% 7/61 • Number of events 9 • 2 weeks
Eye disorders Eye Inflammation	13.1% 8/61 • Number of events 13 • 2 weeks	23.0% 14/61 • Number of events 15 • 2 weeks
Eye disorders Eye Pruritus	9.8% 6/61 • Number of events 6 • 2 weeks	3.3% 2/61 • Number of events 2 • 2 weeks
Eye disorders Foreign Body Sensation	13.1% 8/61 • Number of events 8 • 2 weeks	9.8% 6/61 • Number of events 7 • 2 weeks
Eye disorders Photophobia	13.1% 8/61 • Number of events 10 • 2 weeks	27.9% 17/61 • Number of events 18 • 2 weeks
Eye disorders Vision Blurred	6.6% 4/61 • Number of events 4 • 2 weeks	3.3% 2/61 • Number of events 2 • 2 weeks
Eye disorders Ocular Hyperemia	0.00% 0/61 • 2 weeks	9.8% 6/61 • Number of events 6 • 2 weeks

Additional Information

Tim McNamara, PharmD

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