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

Phase 2TerminatedNCT01214174

ICON Bioscience Inc42 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Ocular Inflammation

Interventions

IBI-10090DRUG

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)

Drs. Fine, Hoffman, and Packer

Eugene, Oregon, United States

Outcomes

Primary Outcomes

Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment

This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment in the study eye. The proportion of patients with anterior chamber cell count = 0 at Day 8 in the study eye for each dosage group will be compared. Only one eye was treated per participant.

Time frame: 8 days post-treatment

Data from ClinicalTrials.gov

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