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

Phase 2

Terminated

• Conditions: Inflammatory Reaction Due to Ocular Lens Prosthesis
• Interventions: Drug: IBI-10090

• Registration Number: NCT01048593
• Lead Sponsor: ICON Bioscience Inc

Brief Summary

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

Detailed Description

All patients received active treatment in this study. Dose group 1 received 114ug of dexamethasone, Dose group 2 received 513ug and Dose group 3 received 684ug.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Results First Submitted: 2012-05-24
• Results First Submitted QC: 2012-07-09
• Results First Posted: 2012-08-16
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-06
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 1	IBI-10090	114ug
Dose 2	IBI-10090	513ug
Dose 3	IBI-10090	684ug

Primary Outcome Measures

Name	Time	Method
Clearance of Anterior Chamber Cells	Day 8 post treatment	Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber cells (ACC) graded on a scale of 0 to 4. The primary efficacy endpoint was complete clearing of ACC, where grade 0 = 0 cells in the anterior chamber on POD 8.

Secondary Outcome Measures

Name	Time	Method
Anterior Chamber Flare (ACF) Grade	Day 90 post-treatment	Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber flare (ACF) graded on a scale of 0 to 4.
Anterior Chamber Cell Grade	Day 90 post-treatment	Anterior chamber cells (ACC) grade was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 4.
Conjunctival Erythema Grade	Day 90 post-treatment	Conjunctival erythema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.
Corneal Edema Grade	Day 90 post-treatment	Cornea edema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.

Trial Locations

Locations (1)

Altos Eye Physicians; 🇺🇸 Los Altos, California, United States