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

November 6, 2018 updated by: ICON Bioscience Inc

A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 in Cataract Surgery Patients

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Altos, California, United States, 94024
        • Altos Eye Physicians

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose 1
114ug
Drug: IBI-10090
Single intraocular injection
Experimental: Dose 2
513ug
Drug: IBI-10090
Single intraocular injection
Experimental: Dose 3
684ug
Drug: IBI-10090
Single intraocular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clearance of Anterior Chamber Cells
Time Frame: Day 8 post treatment
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.
Day 8 post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anterior Chamber Flare (ACF) Grade
Time Frame: Day 90 post-treatment
Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber flare (ACF) graded on a scale of 0 to 4.
Day 90 post-treatment
Conjunctival Erythema Grade
Time Frame: Day 90 post-treatment
Conjunctival erythema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.
Day 90 post-treatment
Corneal Edema Grade
Time Frame: Day 90 post-treatment
Cornea edema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.
Day 90 post-treatment
Anterior Chamber Cell Grade
Time Frame: Day 90 post-treatment
Anterior chamber cells (ACC) grade was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 4.
Day 90 post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ICON Bioscience Inc

Investigators

  • Principal Investigator: David Chang, MD, Altos Eye Physicians

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

January 11, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (Estimate)

January 13, 2010

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

November 6, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C09-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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