Trial | NCT01048593

Trial | NCT01048593 Report issue

Title

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

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

Phase
Phase 2

Lead Sponsor
ICON

Study Type
Interventional

Status
Terminated Results Posted

Indication/Condition
Inflammatory Reaction Due to Ocular Lens Prosthesis

Intervention/Treatment
dexamethasone ...
IBI-10090

Study Participants
6

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

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 Started

Jan 31

2010

Primary Completion

May 31

2010

Study Completion

Jun 30

2010

Results Posted

Aug 16

2012

Estimate

Last Update

Dec 04

2018

Drug IBI-10090

Single intraocular injection

dexamethasone

Dose 1 Experimental

114ug

Drug IBI-10090

Dose 2 Experimental

513ug

Drug IBI-10090

Dose 3 Experimental

684ug

Drug IBI-10090

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.

Summary

Dose 1

Dose 2

Dose 3

All Events

Event Type	Organ System	Event Term	Dose 1	Dose 2	Dose 3

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.

Dose 1

Baseline

POD 8

Dose 2

Baseline

POD 8

Dose 3

Baseline

POD 8

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.

Dose 1

Baseline

POD 1

POD 15

POD 3

POD 30

POD 8

POD 90

Dose 2

Baseline

POD 1

POD 15

POD 3

POD 30

POD 8

POD 90

Dose 3

Baseline

POD 1

POD 15

POD 3

POD 30

POD 8

POD 90

Conjunctival Erythema Grade

Conjunctival erythema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.

Dose 1

Baseline

POD 1

POD 15

POD 3

POD 30

POD 8

POD 90

Dose 2

Baseline

POD 1

POD 15

POD 3

POD 30

POD 8

POD 90

Dose 3

Baseline

POD 1

POD 15

POD 3

POD 30

POD 8

POD 90

Corneal Edema Grade

Cornea edema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.

Dose 1

Baseline

POD 1

POD 15

POD 3

POD 30

POD 8

POD 90

Dose 2

Baseline

POD 1

POD 15

POD 3

POD 30

POD 8

POD 90

Dose 3

Baseline

POD 1

POD 15

POD 3

POD 30

POD 8

POD 90

Anterior Chamber Cell Grade

Anterior chamber cells (ACC) grade was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 4.