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Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

NCT ID: NCT00853970

Last Updated: 2013-01-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

299 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-12-31

Brief Summary

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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

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 0.09%

dosed 1 drop daily in study eye for 2 weeks

Group Type EXPERIMENTAL

Bromfenac Ophthalmic Solution

Intervention Type DRUG

sterile ophthalmic solution

Placebo

dosed 1 drop daily in study eye for 2 weeks

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

sterile ophthalmic solution

Interventions

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Bromfenac Ophthalmic Solution

sterile ophthalmic solution

Intervention Type DRUG

Placebo Comparator

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

References

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Silverstein SM, Cable MG, Sadri E, Peace JH, Fong R, Chandler SP, Gow JA, Klier SM, McNamara TR; Bromfenac Ophthalmic Solution Once Daily (Bromday) Study Group. Once daily dosing of bromfenac ophthalmic solution 0.09% for postoperative ocular inflammation and pain. Curr Med Res Opin. 2011 Sep;27(9):1693-703. doi: 10.1185/03007995.2011.597663. Epub 2011 Jul 14.

Reference Type DERIVED
PMID: 21751945 (View on PubMed)

Other Identifiers

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CL-S&E-1205081-P

Identifier Type: -

Identifier Source: org_study_id

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