Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00704418
• Collaborator: (none)
• Enrollment: 156
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 8.7

Study Details

Study Description

Brief Summary

Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: Bromfenac; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 156 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bromfenac Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily	Drug: Bromfenac; sterile ophthalmic solution
Placebo Comparator: Placebo Placebo, dosed 1 drop daily	Drug: Placebo; sterile ophthalmic solution

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero [Day 15]

   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)

Secondary Outcome Measures

1. Number of Participants That Are Pain Free [Day 1]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Scheduled for cataract surgery

Exclusion Criteria:

• Known hypersensitivity to bromfenac and salicylates

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ISTA Pharmaceuticals, Inc.	Irvine	California	United States	92618

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00704418
• Other Study ID Numbers: CL-S&E-0415081-P-WR
• First Posted: Jun 24, 2008
• Last Update Posted: Jan 18, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Bausch & Lomb Incorporated: Cataract extraction; intraocular lens implantation
• Additional relevant MeSH terms: Cataract; Bromfenac

Study Results

Participant Flow

Recruitment Details	This study was conducted at 19 sites, first participant entered the study 06/03/2008 and last participant completed the study 08/29/2008.
Pre-assignment Detail	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.

Arm/Group Title	Bromfenac	Placebo
Arm/Group Description	Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily	Placebo, dosed 1 drop daily
Period Title: Overall Study
STARTED	78	78
COMPLETED	73	72
NOT COMPLETED	5	6

Baseline Characteristics

Arm/Group Title	Bromfenac	Placebo	Total
Arm/Group Description	Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily	Placebo, dosed 1 drop daily	Total of all reporting groups
Overall Participants	78	78	156
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	68.7	68.0	68.4
Sex: Female, Male (Count of Participants)
Female	45 57.7%	48 61.5%	93 59.6%
Male	33 42.3%	30 38.5%	63 40.4%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero
Description	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)
Time Frame	Day 15

Outcome Measure Data

Analysis Population Description

Last Observation Carried Forward Analysis(LOCF), ITT Population

Arm/Group Title	Bromfenac	Placebo
Arm/Group Description	Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily	Placebo, dosed 1 drop daily
Measure Participants	78	78
Number [participants]	36 46.2%	23 29.5%

2. Secondary Outcome

Title	Number of Participants That Are Pain Free
Description	Participant description of being pain free (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

LOCF Analysis, ITT Population

Arm/Group Title	Bromfenac	Placebo
Arm/Group Description	Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily	Placebo, dosed 1 drop daily
Measure Participants	78	77
Number [participants]	65 83.3%	40 51.3%

Adverse Events

Time Frame	14 days
Arm/Group Title	Bromfenac		Placebo
Arm/Group Description	Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily		Placebo, dosed 1 drop daily
All Cause Mortality
	Bromfenac		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bromfenac		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/73 (0%)		0/73 (0%)
Other (Not Including Serious) Adverse Events
	Bromfenac		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/73 (8.2%)		19/73 (26%)
Eye disorders
Corneal oedema	0/73 (0%)	0	4/73 (5.5%)	5
Eye Pain	2/73 (2.7%)	2	5/73 (6.8%)	5
Eye Inflammation	4/73 (5.5%)	5	10/73 (13.7%)	12

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.