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Efficacy and Safety of Bromfenac Ophthalmic Solution

NCT ID: NCT00585975

Last Updated: 2013-02-15

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

PHASE2

Total Enrollment

568 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Brief Summary

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This is a safety and efficacy study of bromfenac ophthalmic solution

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Detailed Description

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Conditions

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Cataract Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Bromfenac Ophthalmic Solution 0.18%

Group Type EXPERIMENTAL

bromfenac ophthalmic solution

Intervention Type DRUG

sterile opthalmic solution

Xibrom 0.09%

Group Type EXPERIMENTAL

bromfenac ophthalmic solution

Intervention Type DRUG

sterile opthalmic solution

Interventions

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bromfenac ophthalmic solution

sterile opthalmic solution

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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CL-S&E-0802071-P

Identifier Type: -

Identifier Source: org_study_id

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