Efficacy and Safety of IBI-10090 in Ocular Surgery Patients

Phase 2

Completed

• Conditions: Inflammation Associated With Cataract Surgery
• Interventions: Drug: IBI-10090

• Registration Number: NCT01606735
• Lead Sponsor: ICON Bioscience Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-05-25
• Study First Posted: 2012-05-28
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-09
• Results First Submitted: 2014-09-02
• Results First Submitted QC: 2014-09-17
• Last Update Submitted: 2014-09-17
• Results First Posted: 2014-09-22
• Last Update Posted: 2014-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• Patients scheduled for unilateral cataract surgery

Exclusion Criteria

• Ocular, topical, or oral corticosteroids within 7 days of Day 0

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 2	IBI-10090	-
Dose 1	IBI-10090	-
Dose 3	IBI-10090	-

Primary Outcome Measures

Name	Time	Method
Anterior Chamber Cell Count at Day 8 Post-Treatment	8 days post-treatment	This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment. The proportion of patients with anterior chamber cell count = 0 at Day 8 for each dosage group will be compared.

Trial Locations

Locations (2)

Inland Eye Specialists; 🇺🇸 Hemet, California, United States

California Eye Professionals; 🇺🇸 Temecula, California, United States