Efficacy and Safety of IBI-10090 in Ocular Surgery Patients

NCT ID: NCT01606735

Last Updated: 2014-09-22

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

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-03-31

Brief Summary

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This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after ocular surgery.

Detailed Description

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Conditions

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Inflammation Associated With Cataract Surgery

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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Dose 1

Group Type EXPERIMENTAL

IBI-10090

Intervention Type DRUG

dexamethasone

Dose 2

Group Type EXPERIMENTAL

IBI-10090

Intervention Type DRUG

dexamethasone

Dose 3

Group Type EXPERIMENTAL

IBI-10090

Intervention Type DRUG

dexamethasone

Interventions

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IBI-10090

dexamethasone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for unilateral cataract surgery

Exclusion Criteria

* Ocular, topical, or oral corticosteroids within 7 days of Day 0
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ICON Bioscience Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wendy Murahashi, MD

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

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Inland Eye Specialists

Hemet, California, United States

Site Status

California Eye Professionals

Temecula, California, United States

Site Status

Countries

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United States

Other Identifiers

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C11-01

Identifier Type: -

Identifier Source: org_study_id

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