Trial Outcomes & Findings for Efficacy and Safety of Bromfenac Ophthalmic Solution (NCT NCT00585975)

NCT ID: NCT00585975

Last Updated: 2013-02-15

Results Overview

Participants with SOIS of 1. 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: PHASE2
• Target enrollment: 568 participants
• Primary outcome timeframe: Day 15
• Results posted on: 2013-02-15

Participant Flow

Participant milestones

Measure	Bromfenac Ophthalmic Solution 0.18%	Xibrom 0.09%
Overall Study STARTED	277	291
Overall Study COMPLETED	262	278
Overall Study NOT COMPLETED	15	13

Reasons for withdrawal

Measure	Bromfenac Ophthalmic Solution 0.18%	Xibrom 0.09%
Overall Study Withdrawal by Subject	3	3
Overall Study Lost to Follow-up	2	1
Overall Study Enrollment met/over-enrolled	10	9

Baseline Characteristics

Efficacy and Safety of Bromfenac Ophthalmic Solution

Baseline characteristics by cohort

Measure	Bromfenac Ophthalmic Solution 0.18% n=277 Participants	Xibrom 0.09% n=291 Participants	Total n=568 Participants Total of all reporting groups
Age Continuous	68.8 years n=5 Participants	68.6 years n=7 Participants	68.7 years n=5 Participants
Sex: Female, Male Female	169 Participants n=5 Participants	154 Participants n=7 Participants	323 Participants n=5 Participants
Sex: Female, Male Male	108 Participants n=5 Participants	137 Participants n=7 Participants	245 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 15

Participants with SOIS of 1. 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

Measure	Bromfenac Ophthalmic Solution 0.18% n=277 Participants	Xibrom 0.09% n=291 Participants
Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero	157 Participant	164 Participant

SECONDARY outcome

Timeframe: Day 1

Participant description of being pain free taken from patient questionnaire with multiple possible responses

Outcome measures

Measure	Bromfenac Ophthalmic Solution 0.18% n=277 Participants	Xibrom 0.09% n=291 Participants
Number of Participants That Are Pain Free	221 Participant	235 Participant

Adverse Events

Bromfenac Ophthalmic Solution 0.18%

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Xibrom 0.09%

Serious events: 3 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bromfenac Ophthalmic Solution 0.18% n=266 participants at risk	Xibrom 0.09% n=278 participants at risk
Skin and subcutaneous tissue disorders Skin Necrosis	0.38% 1/266	0.00% 0/278
Skin and subcutaneous tissue disorders Abnormal Skin Odor	0.38% 1/266	0.00% 0/278
Cardiac disorders Atrial Fibrillation	0.38% 1/266	0.00% 0/278
Eye disorders Anterior Chamber Inflammation	0.00% 0/266	0.36% 1/278
Gastrointestinal disorders Upper Abdominal Pain	0.00% 0/266	0.36% 1/278
Renal and urinary disorders Kidney Infection	0.00% 0/266	0.36% 1/278

Other adverse events

Measure	Bromfenac Ophthalmic Solution 0.18% n=266 participants at risk	Xibrom 0.09% n=278 participants at risk
Eye disorders Conjunctival Hyperaemia	4.9% 13/266	6.8% 19/278

Additional Information

Tim McNamara, PharmD

ISTA Pharmaceuticals, Inc.

Phone: 949-788-6000

Email: tmcnamara@istavision.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI will provide to the sponsor a copy of the proposed publication information for review, comment and approval following completion of the study and at least sixty (60) days prior to submission for publication of any manuscript, or at least thirty (30) days prior to submission for publication of any abstract. If sponsor requests in writing, the PI will withhold publication for an additional sixty (60) days.
• Publication restrictions are in place

Restriction type: OTHER