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

ICON Bioscience

Status and phase: Terminated; Phase 2

Conditions: Ocular Inflammation

Treatments: Drug: IBI-10090

Study type: Interventional

Funder types: Industry

Identifiers

NCT01214174

C10-01

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 3 patient groups

Dose 1

Experimental group

Description:

513ug

Treatment:

Drug: IBI-10090

Dose 2

Experimental group

Description:

776ug

Treatment:

Drug: IBI-10090

Dose 3

Experimental group

Description:

1046ug

Treatment:

Drug: IBI-10090