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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of IBI-10090 in Ocular Surgery Patients

NCT01606735

Inflammation Associated With Cataract Surgery

COMPLETED PHASE2

The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery

NCT02006888

Inflammation Cataracts

COMPLETED PHASE3

Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery

NCT02547623

Cataract

COMPLETED PHASE3

Indomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery

NCT00904904

Cataract Inflammation

COMPLETED PHASE4

Modified Intraocular Lens to Reduce Eye Inflammation After Cataract Surgery in Uveitis Patients

NCT00001311

Cataracts

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammatory Reaction Due to Ocular Lens Prosthesis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dose 1

114ug

Group Type EXPERIMENTAL

IBI-10090

Intervention Type DRUG

Single intraocular injection

Dose 2

513ug

Group Type EXPERIMENTAL

IBI-10090

Intervention Type DRUG

Single intraocular injection

Dose 3

684ug

Group Type EXPERIMENTAL

IBI-10090

Intervention Type DRUG

Single intraocular injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IBI-10090

Single intraocular injection

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No