Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00853970
• Collaborator: (none)
• Enrollment: 299
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 30

Study Details

Study Description

Brief Summary

Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery

Condition or Disease	Intervention/Treatment	Phase
Pain; Inflammation	Drug: Bromfenac Ophthalmic Solution; Drug: Placebo Comparator	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 299 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bromfenac ophthalmic solution 0.09% dosed 1 drop daily in study eye for 2 weeks	Drug: Bromfenac Ophthalmic Solution; sterile ophthalmic solution
Placebo Comparator: Placebo dosed 1 drop daily in study eye for 2 weeks	Drug: Placebo Comparator; sterile ophthalmic solution

Outcome Measures

Primary Outcome Measures

1. Summed Ocular Inflammation Score (SOIS) of Zero [Day 15 (Primary Endpoint)]

   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)

Secondary Outcome Measures

1. Pain Free [Day 1]

   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.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Male or female at least 18 years of age who are scheduled for unilateral cataract surgery

Exclusion Criteria:

• Have known hypersensitivity to bromfenac or to any component of the investigational product

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

• Study Director: Tim McNamara, PharmD, ISTA Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00853970
• Other Study ID Numbers: CL-S&E-1205081-P
• First Posted: Mar 2, 2009
• Last Update Posted: Jan 25, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Bausch & Lomb Incorporated: Pain and Inflammation as a function of cataract surgery
• Additional relevant MeSH terms: Inflammation; Bromfenac; Ophthalmic Solutions

Study Results

Participant Flow

Recruitment Details	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
Pre-assignment Detail	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.

Arm/Group Title	Bromfenac Ophthalmic Solution 0.09%	Placebo
Arm/Group Description	dosed 1 drop daily into the study eye for 2 weeks	dosed 1 drop daily into the study eye for 2 weeks
Period Title: Overall Study
STARTED	152	147
COMPLETED	146	144
NOT COMPLETED	6	3

Baseline Characteristics

Arm/Group Title	Bromfenac Ophthalmic Solution 0.09%	Placebo	Total
Arm/Group Description	one drop daily in study eye for 2 weeks	one drop daily in study eye for 2 weeks	Total of all reporting groups
Overall Participants	152	147	299
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	70.4	69.1	69.8
Sex: Female, Male (Count of Participants)
Female	89 58.6%	99 67.3%	188 62.9%
Male	63 41.4%	48 32.7%	111 37.1%

Outcome Measures

1. Primary Outcome

Title	Summed Ocular Inflammation Score (SOIS) of Zero
Description	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)
Time Frame	Day 15 (Primary Endpoint)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Bromfenac Ophthalmic Solution 0.09%	Placebo
Arm/Group Description	one drop daily in study eye for 2 weeks	one drop daily in study eye for 2 weeks
Measure Participants	152	147
Number [participants]	70 46.1%	36 24.5%

2. Secondary Outcome

Title	Pain Free
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Bromfenac Ophthalmic Solution 0.09%	Placebo
Arm/Group Description	one drop daily in study eye for 2 weeks	one drop daily in study eye for 2 weeks
Measure Participants	152	147
Number [participants]	135 88.8%	105 71.4%

Adverse Events

Time Frame	2 weeks
Arm/Group Title	Bromfenac Ophthalmic Solution 0.09%		Placebo
Arm/Group Description	one drop daily in study eye for 2 weeks		one drop daily in study eye for 2 weeks
All Cause Mortality
	Bromfenac Ophthalmic Solution 0.09%		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bromfenac Ophthalmic Solution 0.09%		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/147 (0%)		3/144 (2.1%)
Endocrine disorders
Acute and chronic pancreatitis	0/146 (0%)	0	1/144 (0.7%)	1
Surgical and medical procedures
Eye and ear procedural complications	0/146 (0%)	0	2/144 (1.4%)	2
Other (Not Including Serious) Adverse Events
	Bromfenac Ophthalmic Solution 0.09%		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	69/147 (46.9%)		86/144 (59.7%)
Eye disorders
Conjunctival hyperemia	7/147 (4.8%)	7	9/144 (6.3%)	10
Lacrimation increased	5/147 (3.4%)	5	11/144 (7.6%)	11
Eye Pain	13/147 (8.8%)	15	34/144 (23.6%)	37
Eye Inflammation	15/147 (10.2%)	15	21/144 (14.6%)	22
Foreign body sensation	18/147 (12.2%)	21	20/144 (13.9%)	20
Blurred Vision	15/147 (10.2%)	15	11/144 (7.6%)	11
Ocular Hyperemia	4/147 (2.7%)	4	15/144 (10.4%)	18
Photophobia	11/147 (7.5%)	11	26/144 (18.1%)	26

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.