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

• Sponsor: ICON Bioscience Inc (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01214174
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 3
• Duration (Months): 19
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ocular Inflammation	Drug: IBI-10090	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, 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 in Treating Inflammation in Cataract Surgery Patients
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose 1 513ug	Drug: IBI-10090
Experimental: Dose 2 776ug	Drug: IBI-10090
Experimental: Dose 3 1046ug	Drug: IBI-10090

Outcome Measures

Primary Outcome Measures

1. Proportion of Patients With Anterior Chamber Cell Clearing 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 in the study eye. The proportion of patients with anterior chamber cell count = 0 at Day 8 in the study eye for each dosage group will be compared. Only one eye was treated per participant.

Eligibility Criteria

Criteria

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Drs. Fine, Hoffman, and Packer	Eugene	Oregon	United States	97401

Sponsors and Collaborators

• ICON Bioscience Inc

Investigators

• Principal Investigator: Mark Packer, MD, Drs. Fine, Hoffman, Packer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ICON Bioscience Inc
• ClinicalTrials.gov Identifier: NCT01214174
• Other Study ID Numbers: C10-01
• First Posted: Oct 4, 2010
• Last Update Posted: Sep 18, 2013
• Last Verified: Sep 1, 2013

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

Study Results

Participant Flow

Arm/Group Title	Dose 1	Dose 2	Dose 3
Arm/Group Description	IBI-10090 513ug	IBI-10090 776ug	IBI-10090 1046ug
Period Title: Overall Study
STARTED	13	16	14
COMPLETED	13	16	13
NOT COMPLETED	0	0	1

Baseline Characteristics

Arm/Group Title	Dose 1	Dose 2	Dose 3	Total
Arm/Group Description	IBI-10090 513ug	IBI-10090 776ug	IBI-10090 1046ug	Total of all reporting groups
Overall Participants	13	16	13	42
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	2 15.4%	3 18.8%	2 15.4%	7 16.7%
>=65 years	11 84.6%	13 81.3%	11 84.6%	35 83.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.9 (5.5)	72.4 (8.9)	73.5 (7.2)	72.3 (7.4)
Sex: Female, Male (Count of Participants)
Female	4 30.8%	6 37.5%	7 53.8%	17 40.5%
Male	9 69.2%	10 62.5%	6 46.2%	25 59.5%
Region of Enrollment (participants) [Number]
United States	13 100%	16 100%	13 100%	42 100%

Outcome Measures

1. Primary Outcome

Title	Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment
Description	This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment in the study eye. The proportion of patients with anterior chamber cell count = 0 at Day 8 in the study eye for each dosage group will be compared. Only one eye was treated per participant.
Time Frame	8 days post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dose 1	Dose 2	Dose 3
Arm/Group Description	IBI-10090 513ug	IBI-10090 776ug	IBI-10090 1046ug
Measure Participants	13	16	13
Number (95% Confidence Interval) [percentage of patients with ACC clearing]	30.8	25	46.2

Adverse Events

Arm/Group Title	Dose 1		Dose 2		Dose 3
Arm/Group Description	IBI-10090 513ug		IBI-10090 776ug		IBI-10090 1046ug
All Cause Mortality
	Dose 1		Dose 2		Dose 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Dose 1		Dose 2		Dose 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		1/16 (6.3%)		3/13 (23.1%)
Eye disorders
Neovascular age-related macular degeneration	0/13 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0
Endophthalmitis	0/13 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1
Musculoskeletal and connective tissue disorders
Rib fracture	0/13 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia	0/13 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1
Other (Not Including Serious) Adverse Events
	Dose 1		Dose 2		Dose 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/13 (76.9%)		13/16 (81.3%)		13/13 (100%)
Eye disorders
Eye Disorders	10/13 (76.9%)	13	13/16 (81.3%)	25	12/13 (92.3%)	19
Infections and infestations
Infections and Infestations	1/13 (7.7%)	1	0/16 (0%)	0	5/13 (38.5%)	5
Investigations
Investigations	2/13 (15.4%)	2	1/16 (6.3%)	1	5/13 (38.5%)	5
Musculoskeletal and connective tissue disorders
Back pain	1/13 (7.7%)	1	1/16 (6.3%)	1	1/13 (7.7%)	1
Nervous system disorders
Headache	1/13 (7.7%)	1	1/16 (6.3%)	1	0/13 (0%)	0

Limitations/Caveats

Early termination leading to small numbers of subjects analyzed

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.