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Aqueous Humor Concentration of InSite Vision (ISV) 303 (Bromfenac in DuraSite) to Bromday Once Daily (QD) Prior to Cataract Surgery

NCT ID: NCT01387464

Last Updated: 2021-11-19

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-08-31

Brief Summary

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The purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium in subjects administered multiple topical ocular doses of ISV-303 or Bromday™ QD prior to routine cataract surgery.

Detailed Description

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Conditions

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Cataract

Keywords

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bromfenac concentrations ISV-303 Bromday

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ISV-303

Group Type EXPERIMENTAL

ISV-303

Intervention Type DRUG

0.075% bromfenac in DuraSite dosed QD

Bromday™

Group Type ACTIVE_COMPARATOR

Bromday™

Intervention Type DRUG

0.09% bromfenac dosed QD

Interventions

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ISV-303

0.075% bromfenac in DuraSite dosed QD

Intervention Type DRUG

Bromday™

0.09% bromfenac dosed QD

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects age 18 or older scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation
* If a female is of childbearing potential, the subject must agree to and submit a urine sample for pregnancy testing at Visit 1 prior to enrollment and at the end of the study, and the subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months.
* Signature of the subject on the Informed Consent Form
* Willing and able to follow all instructions and attend all study visits
* Able to self-administer study drug (or have a caregiver available to instill all doses of study drug)

Exclusion Criteria

* Use of any drug containing bromfenac within 2 weeks prior to surgery
* Contact lens wear during the dosing period
* Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the investigational medicinal product (IMP) or any of the procedural medications
* Any serious complications with or macroscopic damage to the corneal epithelium
* Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test
* Currently suffer from alcohol and/or drug abuse
* Prior participation in this study protocol
* Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
* A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Pharmaceutical Industries Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

Other Identifiers

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C-11-303-002

Identifier Type: -

Identifier Source: org_study_id