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Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Primary Purpose

Cataract

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
bromfenac ophthalmic solution
placebo
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Cataract extraction with intraocular lens implantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Scheduled for cataract surgery

Exclusion Criteria:

  • Known hypersensitivity to bromfenac and salicylates

Sites / Locations

  • ISTA Pharmaceuticals, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bromfenac

Placebo

Arm Description

Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily

Placebo, Dosed 1 Drop Daily

Outcomes

Primary Outcome Measures

Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero
Participants with SOIS of 0. 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

Number of Participants That Are Pain Free
Participant description of being pain free taken from patient questionnaire with multiple possible responses (None, Mild, Moderate, Severe) within one hour of instilling eye drop

Full Information

First Posted
June 20, 2008
Last Updated
March 4, 2015
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00703781
Brief Title
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract extraction with intraocular lens implantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bromfenac
Arm Type
Experimental
Arm Description
Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, Dosed 1 Drop Daily
Intervention Type
Drug
Intervention Name(s)
bromfenac ophthalmic solution
Intervention Description
sterile ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
sterile ophthalmic solution
Primary Outcome Measure Information:
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 (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
Secondary Outcome Measure Information:
Title
Number of Participants That Are Pain Free
Description
Participant description of being pain free taken from patient questionnaire with multiple possible responses (None, Mild, Moderate, Severe) within one hour of instilling eye drop
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled for cataract surgery Exclusion Criteria: Known hypersensitivity to bromfenac and salicylates
Facility Information:
Facility Name
ISTA Pharmaceuticals, Inc.
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States

12. IPD Sharing Statement

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Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

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