Efficacy and Safety of IBI-10090 in Ocular Surgery Patients

• Sponsor: ICON Bioscience Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01606735
• Collaborator: (none)
• Enrollment: 172
• Locations: 2
• Arms: 3
• Duration (Months): 11
• Patients Per Site: 86
• Patients Per Site Per Month: 7.8

Study Details

Study Description

Brief Summary

This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after ocular surgery.

Condition or Disease	Intervention/Treatment	Phase
Inflammation Associated With Cataract Surgery	Drug: IBI-10090	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 172 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Ocular Surgery
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose 1	Drug: IBI-10090; dexamethasone
Experimental: Dose 2	Drug: IBI-10090; dexamethasone
Experimental: Dose 3	Drug: IBI-10090; dexamethasone

Outcome Measures

Primary Outcome Measures

1. Anterior Chamber Cell Count at Day 8 Post-Treatment [8 days post-treatment]

   This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment. The proportion of patients with anterior chamber cell count = 0 at Day 8 for each dosage group will be compared.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients scheduled for unilateral cataract surgery

Exclusion Criteria:

• Ocular, topical, or oral corticosteroids within 7 days of Day 0

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inland Eye Specialists	Hemet	California	United States	92545
2	California Eye Professionals	Temecula	California	United States	92591

Sponsors and Collaborators

• ICON Bioscience Inc

Investigators

• Study Director: Wendy Murahashi, MD, Sponsor GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ICON Bioscience Inc
• ClinicalTrials.gov Identifier: NCT01606735
• Other Study ID Numbers: C11-01
• First Posted: May 28, 2012
• Last Update Posted: Sep 22, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by ICON Bioscience Inc: cataract surgery; ocular inflammation
• Additional relevant MeSH terms: Cataract; Inflammation

Study Results

Participant Flow

Arm/Group Title	342 mcg	517 mcg	697 mcg
Arm/Group Description	IBI-10090: dexamethasone	IBI-10090: dexamethasone	IBI-10090: dexamethasone
Period Title: Overall Study
STARTED	58	56	58
COMPLETED	58	56	58
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	342 mcg	517 mcg	697 mcg	Total
Arm/Group Description	IBI-10090: dexamethasone	IBI-10090: dexamethasone	IBI-10090: dexamethasone	Total of all reporting groups
Overall Participants	58	56	58	172
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68 (8.9)	71.8 (71.8)	70.1 (10)	70.1 (9.2)
Sex: Female, Male (Count of Participants)
Female	35 60.3%	39 69.6%	31 53.4%	105 61%
Male	23 39.7%	17 30.4%	27 46.6%	67 39%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 3.4%	1 1.8%	0 0%	3 1.7%
Asian	2 3.4%	2 3.6%	6 10.3%	10 5.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	1 1.7%	1 0.6%
Black or African American	1 1.7%	1 1.8%	5 8.6%	7 4.1%
White	50 86.2%	51 91.1%	45 77.6%	146 84.9%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	3 5.2%	1 1.8%	1 1.7%	5 2.9%
Region of Enrollment (participants) [Number]
United States	58 100%	56 100%	58 100%	172 100%

Outcome Measures

1. Primary Outcome

Title	Anterior Chamber Cell Count at Day 8 Post-Treatment
Description	This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment. The proportion of patients with anterior chamber cell count = 0 at Day 8 for each dosage group will be compared.
Time Frame	8 days post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	342 mcg	517 mcg	697 mcg
Arm/Group Description	IBI-10090: dexamethasone	IBI-10090: dexamethasone	IBI-10090: dexamethasone
Measure Participants	58	56	58
Number (95% Confidence Interval) [percentage of patients with ACC clearing]	50	51.8	60.3

Adverse Events

Arm/Group Title	342 mcg		517 mcg		697 mcg
Arm/Group Description	IBI-10090: dexamethasone		IBI-10090: dexamethasone		IBI-10090: dexamethasone
All Cause Mortality
	342 mcg		517 mcg		697 mcg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	342 mcg		517 mcg		697 mcg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/58 (10.3%)		2/56 (3.6%)		3/58 (5.2%)
Eye disorders
Corneal edema	2/58 (3.4%)		0/56 (0%)		0/58 (0%)
Corneal endothelial cell loss	3/58 (5.2%)		1/56 (1.8%)		3/58 (5.2%)
Endophthalmitis	1/58 (1.7%)		0/56 (0%)		0/58 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma	1/58 (1.7%)		0/56 (0%)		0/58 (0%)
Respiratory, thoracic and mediastinal disorders
Influenza	0/58 (0%)		1/56 (1.8%)		0/58 (0%)
Other (Not Including Serious) Adverse Events
	342 mcg		517 mcg		697 mcg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/58 (3.4%)		2/56 (3.6%)		1/58 (1.7%)
Nervous system disorders
Headache	2/58 (3.4%)		0/56 (0%)		1/58 (1.7%)
Skin and subcutaneous tissue disorders
Dry Skin	0/58 (0%)		2/56 (3.6%)		0/58 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

All information related to this study is considered confidential information belonging to Icon Bioscience, Inc. Data on the use of the study drug and results of all clinical and laboratory studies are considered private and confidential. None of the details, results, or other information for this study shall be published or made known to a third party without written consent from Icon Bioscience, Inc., except for disclosure to regulatory agencies if required by law.