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

Phase 2TerminatedNCT01048593

ICON Bioscience Inc6 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Inflammatory Reaction Due to Ocular Lens Prosthesis

Interventions

IBI-10090DRUG

Single intraocular injection

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Altos Eye Physicians

Los Altos, California, United States

Outcomes

Primary Outcomes

Clearance of Anterior Chamber Cells

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.

Time frame: Day 8 post treatment

Secondary Outcomes

Anterior Chamber Flare (ACF) Grade

Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber flare (ACF) graded on a scale of 0 to 4.

Time frame: Day 90 post-treatment

Conjunctival Erythema Grade

Conjunctival erythema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.

Time frame: Day 90 post-treatment

Corneal Edema Grade

Cornea edema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.

Time frame: Day 90 post-treatment

Anterior Chamber Cell Grade

Anterior chamber cells (ACC) grade was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 4.

Time frame: Day 90 post-treatment

Data from ClinicalTrials.gov

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