Efficacy and Safety of Bromfenac Ophthalmic Solution

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00585975
• Collaborator: (none)
• Enrollment: 568
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

This is a safety and efficacy study of bromfenac ophthalmic solution

Condition or Disease	Intervention/Treatment	Phase
Cataract Surgery	Drug: bromfenac ophthalmic solution	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 568 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bromfenac Ophthalmic Solution 0.18%	Drug: bromfenac ophthalmic solution; sterile opthalmic solution
Experimental: Xibrom 0.09%	Drug: bromfenac ophthalmic solution; sterile opthalmic solution

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male or female greater than or equal to 18 years of age, and scheduled for cataract surgery

Exclusion Criteria:

• Active corneal pathology in either eye

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: NCT00585975
• Other Study ID Numbers: CL-S&E-0802071-P
• First Posted: Jan 4, 2008
• Last Update Posted: Feb 15, 2013
• Last Verified: Feb 1, 2013

• Additional relevant MeSH terms: Cataract; Bromfenac; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	Bromfenac Ophthalmic Solution 0.18%	Xibrom 0.09%
Arm/Group Description
Period Title: Overall Study
STARTED	277	291
COMPLETED	262	278
NOT COMPLETED	15	13

Baseline Characteristics

Arm/Group Title	Bromfenac Ophthalmic Solution 0.18%	Xibrom 0.09%	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	277	291	568
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	68.8	68.6	68.7
Sex: Female, Male (Count of Participants)
Female	169 61%	154 52.9%	323 56.9%
Male	108 39%	137 47.1%	245 43.1%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bromfenac Ophthalmic Solution 0.18%	Xibrom 0.09%
Arm/Group Description
Measure Participants	277	291
Number [Participant]	157	164

2. Secondary Outcome

Title	Number of Participants That Are Pain Free
Description	Participant description of being pain free taken from patient questionnaire with multiple possible responses
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bromfenac Ophthalmic Solution 0.18%	Xibrom 0.09%
Arm/Group Description
Measure Participants	277	291
Number [Participant]	221	235

Adverse Events

Arm/Group Title	Bromfenac Ophthalmic Solution 0.18%		Xibrom 0.09%
Arm/Group Description
All Cause Mortality
	Bromfenac Ophthalmic Solution 0.18%		Xibrom 0.09%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bromfenac Ophthalmic Solution 0.18%		Xibrom 0.09%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/266 (0.8%)		3/278 (1.1%)
Cardiac disorders
Atrial Fibrillation	1/266 (0.4%)		0/278 (0%)
Eye disorders
Anterior Chamber Inflammation	0/266 (0%)		1/278 (0.4%)
Gastrointestinal disorders
Upper Abdominal Pain	0/266 (0%)		1/278 (0.4%)
Renal and urinary disorders
Kidney Infection	0/266 (0%)		1/278 (0.4%)
Skin and subcutaneous tissue disorders
Skin Necrosis	1/266 (0.4%)		0/278 (0%)
Abnormal Skin Odor	1/266 (0.4%)		0/278 (0%)
Other (Not Including Serious) Adverse Events
	Bromfenac Ophthalmic Solution 0.18%		Xibrom 0.09%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/266 (4.9%)		19/278 (6.8%)
Eye disorders
Conjunctival Hyperaemia	13/266 (4.9%)		19/278 (6.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.