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A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease

NCT ID: NCT01212471

Last Updated: 2020-09-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

840 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-12-31

Brief Summary

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A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.

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Detailed Description

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Conditions

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Dry Eye Syndrome

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 A

Bromfenac ophthalmic solution A

Group Type EXPERIMENTAL

Bromfenac Ophthalmic Solution A

Intervention Type DRUG

sterile ophthalmic solution

Bromfenac Ophthalmic Solution B

Bromfenac ophthalmic solution B

Group Type EXPERIMENTAL

Bromfenac Ophthalmic Solution B

Intervention Type DRUG

sterile ophthalmic solution

Placebo Comparator

Placebo Comparator

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

sterile ophthalmic solution

Interventions

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Bromfenac Ophthalmic Solution A

sterile ophthalmic solution

Intervention Type DRUG

Bromfenac Ophthalmic Solution B

sterile ophthalmic solution

Intervention Type DRUG

Placebo Comparator

sterile ophthalmic solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Be of either gender and any race 18 years or older

Exclusion Criteria

* Have a local or systemic disease that could interfere with the assessment of safety or efficacy or that is likely to result in early discontinuation from the study
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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S00007

Identifier Type: -

Identifier Source: org_study_id

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