The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery

• Sponsor: ICON Bioscience Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02006888
• Collaborator: (none)
• Enrollment: 394
• Location: 1
• Arms: 3
• Duration (Months): 9
• Patients Per Site Per Month: 43.9

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether IBI-10090 injection is effective in the treatment of inflammation associated with cataract surgery.

Condition or Disease	Intervention/Treatment	Phase
Inflammation; Cataracts	Drug: IBI-10090; Drug: Placebo	Phase 3

Detailed Description

A double blinded randomized trial to assess the efficacy and safety of IBI-10090, in two separate doses as compared to placebo (ATEC carrier only sans dexamethasone)

Study Design

• Study Type: Interventional
• Actual Enrollment: 394 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IBI-10090 low dose IBI-10090 low dose	Drug: IBI-10090; Other Names: Dexycu
Experimental: IBI-10090 med dose IBI-10090 med dose	Drug: IBI-10090; Other Names: Dexycu
Placebo Comparator: Placebo Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Anterior Chamber Cell Clearing [Day 8]

   The primary efficacy outcome is anterior chamber cell clearing in the study eye at Day 8. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB).

2. Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.

3. The patient must demonstrate best corrected visual acuity (BCVA) of 20/30-20/200 (with glare testing, if necessary) in the study eye and better than 20/200 in the fellow eye.

4. The patient must be considered by the Investigator to have visual acuity potential greater than 20/30 in the study eye.

5. The patient must have a corneal endothelial cell count by specular microscopy in the study eye of at least 2000 cells/mm2 with normal cell morphology.

6. A female patient of childbearing potential (premenopausal by medical history) must have a negative pregnancy test on Day 0 and be using an effective method of birth control (although no birth control method is 100% effective, the following are considered effective means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception using either a condom or diaphragm with spermicidal gel, an intrauterine device, or contraceptive hormone implant or patch) from Screening for the duration of the study.

7. The patient must be willing and able to understand and comply with the study procedures and to communicate meaningfully with study personnel.

Key Exclusion Criteria:

1. Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0.

2. Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.

3. Patients who have received any intravitreal corticosteroid delivery vehicle (e.g., Retisert, Ozurdex, Iluvien) in the study eye at any time.

4. Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study.

5. Patients with an allergy or hypersensitivity to dexamethasone.

6. Patients who are known steroid responders (corticosteroid-related intraocular pressure elevation in either eye).

7. Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to Day 0.

8. Patients who have undergone prior intraocular (non-laser) surgery in the study eye within 6 months prior to screening.

9. Patients who have undergone prior intraocular laser surgery in the study eye within 3 months prior to screening.

10. Patients with planned intraocular or laser surgery in the study eye for the duration of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hull Eye Center	Lancaster	California	United States	93534

Sponsors and Collaborators

• ICON Bioscience Inc

Investigators

• Study Director: howard franklin, md, ICON Bioscience Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ICON Bioscience Inc
• ClinicalTrials.gov Identifier: NCT02006888
• Other Study ID Numbers: C13-04
• First Posted: Dec 10, 2013
• Last Update Posted: Apr 23, 2018
• Last Verified: Mar 1, 2018

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

Study Results

Participant Flow

Recruitment Details	The first patient was enrolled into the study on 19 December 2013 and the last patient completed the study on 03 October 2014.

Arm/Group Title	IBI-10090 Low Dose	IBI-10090 Med Dose	Placebo
Arm/Group Description	IBI-10090 low dose IBI-10090	IBI-10090 med dose IBI-10090	Placebo Placebo: Placebo
Period Title: Overall Study
STARTED	158	156	80
COMPLETED	122	122	58
NOT COMPLETED	36	34	22

Baseline Characteristics

Arm/Group Title	IBI-10090 Low Dose	IBI-10090 Med Dose	Placebo	Total
Arm/Group Description	IBI-10090 low dose IBI-10090	IBI-10090 med dose IBI-10090	Placebo Placebo: Placebo	Total of all reporting groups
Overall Participants	158	156	80	394
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	41 25.9%	41 26.3%	17 21.3%	99 25.1%
>=65 years	117 74.1%	115 73.7%	63 78.8%	295 74.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70 (9)	70 (9)	71 (9)	70 (9)
Sex: Female, Male (Count of Participants)
Female	75 47.5%	69 44.2%	39 48.8%	183 46.4%
Male	83 52.5%	87 55.8%	41 51.3%	211 53.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	19 12%	23 14.7%	14 17.5%	56 14.2%
Not Hispanic or Latino	139 88%	133 85.3%	66 82.5%	338 85.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.6%	3 1.9%	0 0%	4 1%
Asian	4 2.5%	1 0.6%	1 1.3%	6 1.5%
Native Hawaiian or Other Pacific Islander	2 1.3%	1 0.6%	0 0%	3 0.8%
Black or African American	17 10.8%	21 13.5%	11 13.8%	49 12.4%
White	129 81.6%	123 78.8%	67 83.8%	319 81%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	5 3.2%	7 4.5%	1 1.3%	13 3.3%
Region of Enrollment (participants) [Number]
United States	158 100%	156 100%	80 100%	394 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Anterior Chamber Cell Clearing
Description	The primary efficacy outcome is anterior chamber cell clearing in the study eye at Day 8. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).
Time Frame	Day 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IBI-10090 Low Dose	IBI-10090 Med Dose	Placebo
Arm/Group Description	IBI-10090 low dose IBI-10090	IBI-10090 med dose IBI-10090	Placebo Placebo: Placebo
Measure Participants	158	156	80
Count of Participants [Participants]	99 62.7%	103 66%	20 25%

Adverse Events

Arm/Group Title	IBI-10090 Low Dose		IBI-10090 Med Dose		Placebo
Arm/Group Description	IBI-10090 low dose IBI-10090		IBI-10090 med dose IBI-10090		Placebo Placebo: Placebo
All Cause Mortality
	IBI-10090 Low Dose		IBI-10090 Med Dose		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/158 (0%)		0/156 (0%)		0/80 (0%)
Serious Adverse Events
	IBI-10090 Low Dose		IBI-10090 Med Dose		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/158 (0.6%)		0/156 (0%)		0/80 (0%)
Eye disorders
Corneal decompensation	1/158 (0.6%)	1	0/156 (0%)	0	0/80 (0%)	0
Other (Not Including Serious) Adverse Events
	IBI-10090 Low Dose		IBI-10090 Med Dose		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/158 (10.1%)		4/156 (2.6%)		7/80 (8.8%)
Eye disorders
eye pain	16/158 (10.1%)	16	4/156 (2.6%)	4	7/80 (8.8%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.