Trial Outcomes & Findings for Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery (NCT NCT01367249)

NCT ID: NCT01367249

Last Updated: 2014-05-06

Results Overview

The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 440 participants
• Primary outcome timeframe: Day 15
• Results posted on: 2014-05-06

Participant Flow

This study was a multi-center, randomized, double-masked, parallel-group, placebo-controlled study, the first subject was enrolled 05/05/2011 and the last subject exited the study 07/29/2011.

440 subjects were enrolled from 39 clinical sites in the United States, of which 416 subjects received at least 1 dose of bromfenac or placebo.

Participant milestones

Measure	Bromfenac Ophthalmic Solution Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. Bromfenac Ophthalmic Solution: Sterile ophthalmic solution	Placebo One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution
Overall Study STARTED	222	218
Overall Study COMPLETED	213	202
Overall Study NOT COMPLETED	9	16

Reasons for withdrawal

Measure	Bromfenac Ophthalmic Solution Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. Bromfenac Ophthalmic Solution: Sterile ophthalmic solution	Placebo One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution
Overall Study Withdrawal by Subject	6	6
Overall Study Other	3	10

Baseline Characteristics

Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

Baseline characteristics by cohort

Measure	Bromfenac Ophthalmic Solution n=222 Participants Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. Bromfenac Ophthalmic Solution: Sterile ophthalmic solution	Placebo n=218 Participants One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution	Total n=440 Participants Total of all reporting groups
Age, Continuous	68.4 years STANDARD_DEVIATION 10.70 • n=5 Participants	68.5 years STANDARD_DEVIATION 9.68 • n=7 Participants	68.5 years STANDARD_DEVIATION 10.19 • n=5 Participants
Sex: Female, Male Female	141 Participants n=5 Participants	146 Participants n=7 Participants	287 Participants n=5 Participants
Sex: Female, Male Male	81 Participants n=5 Participants	72 Participants n=7 Participants	153 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants	17 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) White	167 Participants n=5 Participants	162 Participants n=7 Participants	329 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	28 Participants n=5 Participants	31 Participants n=7 Participants	59 Participants n=5 Participants
Region of Enrollment United States	222 participants n=5 Participants	218 participants n=7 Participants	440 participants n=5 Participants
Iris Color (Study Eye) Blue	57 participants n=5 Participants	65 participants n=7 Participants	122 participants n=5 Participants
Iris Color (Study Eye) Brown	109 participants n=5 Participants	93 participants n=7 Participants	202 participants n=5 Participants
Iris Color (Study Eye) Gray	1 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants
Iris Color (Study Eye) Green	24 participants n=5 Participants	21 participants n=7 Participants	45 participants n=5 Participants
Iris Color (Study Eye) Hazel	31 participants n=5 Participants	33 participants n=7 Participants	64 participants n=5 Participants
Iris Color (Study Eye) Other	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 15

Population: LOCF Analysis, ITT Population

The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15.

Outcome measures

Measure	Bromfenac Ophthalmic Solution n=222 eyes Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. Bromfenac Ophthalmic Solution: Sterile ophthalmic solution	Placebo n=218 eyes One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution
Ocular Inflammation	108 eyes	53 eyes

SECONDARY outcome

Timeframe: Day 1

Population: LOCF Analysis, ITT Population

The proportion of subjects who were free of ocular pain at Day 1. Pain Free defined as a score of "None" on the pain scale of the Ocular Comfort Grading Assessment in the subject diary.

Outcome measures

Measure	Bromfenac Ophthalmic Solution n=222 eyes Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. Bromfenac Ophthalmic Solution: Sterile ophthalmic solution	Placebo n=218 eyes One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution
Ocular Pain	175 eyes	108 eyes

Adverse Events

Bromfenac Ophthalmic Solution

Serious events: 3 serious events

Other events: 29 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bromfenac Ophthalmic Solution n=212 participants at risk Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. Bromfenac Ophthalmic Solution: Sterile ophthalmic solution	Placebo n=204 participants at risk One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution
Cardiac disorders Angina Pectoris	0.47% 1/212 • Number of events 1 • 16 days	0.00% 0/204 • 16 days
Musculoskeletal and connective tissue disorders Hip Fracture	0.47% 1/212 • Number of events 1 • 16 days	0.00% 0/204 • 16 days
Eye disorders Eye operation complication	0.47% 1/212 • Number of events 1 • 16 days	0.00% 0/204 • 16 days
Blood and lymphatic system disorders Deep Vein Thrombosis	0.00% 0/212 • 16 days	0.49% 1/204 • Number of events 1 • 16 days
Cardiac disorders Hypertension	0.00% 0/212 • 16 days	0.49% 1/204 • Number of events 1 • 16 days
Nervous system disorders Asthenia	0.00% 0/212 • 16 days	0.49% 1/204 • Number of events 1 • 16 days
Cardiac disorders Myocarial Infarction	0.00% 0/212 • 16 days	0.49% 1/204 • Number of events 1 • 16 days

Other adverse events

Measure	Bromfenac Ophthalmic Solution n=212 participants at risk Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. Bromfenac Ophthalmic Solution: Sterile ophthalmic solution	Placebo n=204 participants at risk One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution
Eye disorders Anterior Chamber Inflammation	4.7% 10/212 • Number of events 10 • 16 days	8.8% 18/204 • Number of events 18 • 16 days
Eye disorders Conjunctival Hyperemia	1.4% 3/212 • Number of events 3 • 16 days	7.4% 15/204 • Number of events 15 • 16 days
Eye disorders Eye Pain	5.7% 12/212 • Number of events 12 • 16 days	9.8% 20/204 • Number of events 20 • 16 days
Eye disorders Photophobia	1.9% 4/212 • Number of events 4 • 16 days	5.4% 11/204 • Number of events 11 • 16 days

Additional Information

James Gow

Bausch & Lomb Incorporated

Phone: 949-788-6000

Email: james.gow@bausch.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER