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Efficacy and Safety Study of IBI-10090 in Cataract Surgery Patients

NCT ID: NCT01214174

Last Updated: 2013-09-18

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-05-31

Brief Summary

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

Detailed Description

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Conditions

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Ocular Inflammation

Keywords

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cataract inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Dose 1

513ug

Group Type EXPERIMENTAL

IBI-10090

Intervention Type DRUG

Dose 2

776ug

Group Type EXPERIMENTAL

IBI-10090

Intervention Type DRUG

Dose 3

1046ug

Group Type EXPERIMENTAL

IBI-10090

Intervention Type DRUG

Interventions

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IBI-10090

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female patients 40 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation.

Exclusion Criteria

* Patients who have used any ocular, topical, or oral corticosteroids within 7 days prior to Day 0.
* Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to screening.
* Patients with any signs of intraocular inflammation in either eye at screening.
* Patients who have received any prior intravitreal injections in the study eye.
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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Mark Packer, MD

Role: PRINCIPAL_INVESTIGATOR

Drs. Fine, Hoffman, Packer

Locations

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Drs. Fine, Hoffman, and Packer

Eugene, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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C10-01

Identifier Type: -

Identifier Source: org_study_id