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Study to Compare Differing Dosing Regimens of ISV-303 (Bromfenac in DuraSite) to Xibrom and Vehicle in Post Cataract Surgery Volunteers

NCT ID: NCT01190878

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

PHASE1/PHASE2

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-01-31

Brief Summary

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The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-303 compared to vehicle and Xibrom™ when dosed for 2 weeks in post-cataract-surgery volunteers.

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 BID

Group Type EXPERIMENTAL

ISV-303

Intervention Type DRUG

0.075% of bromfenac in DuraSite dosed BID

ISV-303 QD

Group Type EXPERIMENTAL

ISV-303

Intervention Type DRUG

0.075% of bromfenac in DuraSite dosed QD

Xibrom BID

Group Type ACTIVE_COMPARATOR

Xibrom™

Intervention Type DRUG

0.09% bromfenac dosed BID

DuraSite Vehicle BID

Group Type PLACEBO_COMPARATOR

DuraSite Vehicle

Intervention Type DRUG

Vehicle dosed BID

Interventions

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ISV-303

0.075% of bromfenac in DuraSite dosed QD

Intervention Type DRUG

ISV-303

0.075% of bromfenac in DuraSite dosed BID

Intervention Type DRUG

DuraSite Vehicle

Vehicle dosed BID

Intervention Type DRUG

Xibrom™

0.09% bromfenac dosed BID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation on the day prior to study enrollment
* Meet the best corrected visual acuity score requirement
* Meet the IOP requirement

Exclusion Criteria

* Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications or any of the procedural medications
* Use of any ocular topical, or systemic medication that could interfere with normal lacrimation, wound healing, the test agent, or the interpretation of study results, within 1 week prior to Day of Surgery
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

References

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Trattler W, Hosseini K. Twice-Daily vs. Once-Daily Dosing with 0.075% Bromfenac in DuraSite: Outcomes from a 14-Day Phase 2 Study. Ophthalmol Ther. 2017 Dec;6(2):277-284. doi: 10.1007/s40123-017-0102-x. Epub 2017 Aug 17.

Reference Type DERIVED
PMID: 28819932 (View on PubMed)

Other Identifiers

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C-10-303-001

Identifier Type: -

Identifier Source: org_study_id