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

Primary Purpose

Inflammatory Reaction Due to Ocular Lens Prosthesis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IBI-10090
Sponsored by
ICON Bioscience Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Reaction Due to Ocular Lens Prosthesis focused on measuring ocular inflammation cataract surgery, post cataract surgery inflammation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Altos Eye Physicians

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Dose 1

Dose 2

Dose 3

Arm Description

114ug

513ug

684ug

Outcomes

Primary Outcome Measures

Clearance of Anterior Chamber Cells
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.

Secondary Outcome Measures

Anterior Chamber Flare (ACF) Grade
Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber flare (ACF) graded on a scale of 0 to 4.
Conjunctival Erythema Grade
Conjunctival erythema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.
Corneal Edema Grade
Cornea edema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.
Anterior Chamber Cell Grade
Anterior chamber cells (ACC) grade was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 4.

Full Information

First Posted
January 11, 2010
Last Updated
November 6, 2018
Sponsor
ICON Bioscience Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01048593
Brief Title
Efficacy and Safety Study of IBI-10090 in Patients Undergoing Cataract Surgery
Official Title
A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 in Cataract Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated in order to examine study data.
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ICON Bioscience Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Reaction Due to Ocular Lens Prosthesis
Keywords
ocular inflammation cataract surgery, post cataract surgery inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose 1
Arm Type
Experimental
Arm Description
114ug
Arm Title
Dose 2
Arm Type
Experimental
Arm Description
513ug
Arm Title
Dose 3
Arm Type
Experimental
Arm Description
684ug
Intervention Type
Drug
Intervention Name(s)
IBI-10090
Intervention Description
Single intraocular injection
Primary Outcome Measure Information:
Title
Clearance of Anterior Chamber Cells
Description
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.
Time Frame
Day 8 post treatment
Secondary Outcome Measure Information:
Title
Anterior Chamber Flare (ACF) Grade
Description
Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber flare (ACF) graded on a scale of 0 to 4.
Time Frame
Day 90 post-treatment
Title
Conjunctival Erythema Grade
Description
Conjunctival erythema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.
Time Frame
Day 90 post-treatment
Title
Corneal Edema Grade
Description
Cornea edema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.
Time Frame
Day 90 post-treatment
Title
Anterior Chamber Cell Grade
Description
Anterior chamber cells (ACC) grade was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 4.
Time Frame
Day 90 post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Chang, MD
Organizational Affiliation
Altos Eye Physicians
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altos Eye Physicians
City
Los Altos
State/Province
California
ZIP/Postal Code
94024
Country
United States

12. IPD Sharing Statement

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

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