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

ICON Bioscience

Status and phase: Terminated; Phase 2

Conditions: Inflammatory Reaction Due to Ocular Lens Prosthesis

Treatments: Drug: IBI-10090

Study type: Interventional

Funder types: Industry

Identifiers

NCT01048593

C09-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 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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6 participants in 3 patient groups

Dose 1

Experimental group

Description:

114ug

Treatment:

Drug: IBI-10090

Dose 2

Experimental group

Description:

513ug

Treatment:

Drug: IBI-10090

Dose 3

Experimental group

Description:

684ug

Treatment:

Drug: IBI-10090