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Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

NCT ID: NCT01367249

Last Updated: 2014-05-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-12-31

Brief Summary

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This is an efficacy study of Bromfenac Ophthalmic Solution in cataract surgery.

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Detailed Description

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Conditions

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Pain Inflammation Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Bromfenac Ophthalmic Solution

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sterile ophthalmic solution

Interventions

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Bromfenac Ophthalmic Solution

Sterile ophthalmic solution

Intervention Type DRUG

Placebo

Sterile ophthalmic solution

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tim McNamara, PharmD

Role: STUDY_DIRECTOR

ISTA Pharmaceuticals, Inc.

Locations

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ISTA Pharmaceuticals, Inc.

Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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S00124

Identifier Type: -

Identifier Source: org_study_id

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