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Comparison Study of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects

NCT ID: NCT01576952

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

PHASE3

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-01-31

Brief Summary

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The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of topical administration of ISV-303 compared with DuraSite Vehicle.

Detailed Description

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Conditions

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Ocular Inflammation

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

0.075% bromfenac in DuraSite vehicle dosed BID

Group Type EXPERIMENTAL

ISV-303

Intervention Type DRUG

Bromfenac in DuraSite

DuraSite Vehicle

DuraSite Vehicle dosed BID

Group Type PLACEBO_COMPARATOR

DuraSite Vehicle

Intervention Type OTHER

DuraSite Vehicle

Interventions

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ISV-303

Bromfenac in DuraSite

Intervention Type DRUG

DuraSite Vehicle

DuraSite Vehicle

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects age 18 or older scheduled for unilateral cataract surgery with posterior chamber intraocular lens implantation
* If a female is of childbearing potential, the subject must agree to and submit a negative pregnancy test before any protocol-specific procedures are conducted. 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 to avoid disallowed medication for the duration of the study.
* 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

* Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications or any of the procedural medications
* Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
* Currently suffer from alcohol and/or drug abuse
* 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-11-303-003

Identifier Type: -

Identifier Source: org_study_id