Trial Outcomes & Findings for Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery (NCT NCT00853970)

Last Updated: 2013-01-25

Results Overview

Participants with SOIS of 0. Measured on a scale of 0-4: 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

299 participants

Primary outcome timeframe

Day 15 (Primary Endpoint)

Results posted on

2013-01-25

Participant Flow

The first participant entered the study on 02/09/2009, and last participant exited the study on 07/06/2009. This study took place at 41 sites in the USA

152 participants were randomized to the bromfenac ophthalmic solution 0.09% treatment group and 147 were randomized to the placebo treatment group. One hundred forty six of 152 participants (96.1%) in the bromfenac ophthalmic solution 0.09% treatment group and 144/147 (98.0%) participants in the placebo treatment group completed the study.

Participant milestones

Participant milestones
Measure	Bromfenac Ophthalmic Solution 0.09% dosed 1 drop daily into the study eye for 2 weeks	Placebo dosed 1 drop daily into the study eye for 2 weeks
Overall Study STARTED	152	147
Overall Study COMPLETED	146	144
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Bromfenac Ophthalmic Solution 0.09% dosed 1 drop daily into the study eye for 2 weeks	Placebo dosed 1 drop daily into the study eye for 2 weeks
Overall Study Withdrawal by Subject	2	1
Overall Study Cancelled surgery	4	2

Baseline Characteristics

Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bromfenac Ophthalmic Solution 0.09% n=152 Participants one drop daily in study eye for 2 weeks	Placebo n=147 Participants one drop daily in study eye for 2 weeks	Total n=299 Participants Total of all reporting groups
Age Continuous	70.4 years n=5 Participants	69.1 years n=7 Participants	69.8 years n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants	99 Participants n=7 Participants	188 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	48 Participants n=7 Participants	111 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 15 (Primary Endpoint)

Population: Last observation carried forward (LOCF) Analysis; Intent to treat (ITT) Population

Outcome measures

Outcome measures
Measure	Bromfenac Ophthalmic Solution 0.09% n=152 Participants one drop daily in study eye for 2 weeks	Placebo n=147 Participants one drop daily in study eye for 2 weeks
Summed Ocular Inflammation Score (SOIS) of Zero	70 participants	36 participants

SECONDARY outcome

Timeframe: Day 1

Population: Last observation carried forward (LOCF) Analysis, Intent to treat (ITT) Population

Participants that are pain free at day 1, taken from patient questionnaire with multiple possible responses measured on a scale of 0-3, where 0=none and 3=severe.

Outcome measures

Outcome measures
Measure	Bromfenac Ophthalmic Solution 0.09% n=152 Participants one drop daily in study eye for 2 weeks	Placebo n=147 Participants one drop daily in study eye for 2 weeks
Pain Free	135 participants	105 participants

Adverse Events

Bromfenac Ophthalmic Solution 0.09%

Serious events: 0 serious events

Other events: 69 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 86 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bromfenac Ophthalmic Solution 0.09% n=147 participants at risk one drop daily in study eye for 2 weeks	Placebo n=144 participants at risk one drop daily in study eye for 2 weeks
Endocrine disorders Acute and chronic pancreatitis	0.00% 0/146 • 2 weeks	0.69% 1/144 • Number of events 1 • 2 weeks
Surgical and medical procedures Eye and ear procedural complications	0.00% 0/146 • 2 weeks	1.4% 2/144 • Number of events 2 • 2 weeks

Other adverse events

Other adverse events
Measure	Bromfenac Ophthalmic Solution 0.09% n=147 participants at risk one drop daily in study eye for 2 weeks	Placebo n=144 participants at risk one drop daily in study eye for 2 weeks
Eye disorders Conjunctival hyperemia	4.8% 7/147 • Number of events 7 • 2 weeks	6.2% 9/144 • Number of events 10 • 2 weeks
Eye disorders Lacrimation increased	3.4% 5/147 • Number of events 5 • 2 weeks	7.6% 11/144 • Number of events 11 • 2 weeks
Eye disorders Eye Pain	8.8% 13/147 • Number of events 15 • 2 weeks	23.6% 34/144 • Number of events 37 • 2 weeks
Eye disorders Eye Inflammation	10.2% 15/147 • Number of events 15 • 2 weeks	14.6% 21/144 • Number of events 22 • 2 weeks
Eye disorders Foreign body sensation	12.2% 18/147 • Number of events 21 • 2 weeks	13.9% 20/144 • Number of events 20 • 2 weeks
Eye disorders Blurred Vision	10.2% 15/147 • Number of events 15 • 2 weeks	7.6% 11/144 • Number of events 11 • 2 weeks
Eye disorders Ocular Hyperemia	2.7% 4/147 • Number of events 4 • 2 weeks	10.4% 15/144 • Number of events 18 • 2 weeks
Eye disorders Photophobia	7.5% 11/147 • Number of events 11 • 2 weeks	18.1% 26/144 • Number of events 26 • 2 weeks

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