Trial Outcomes & Findings for The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery (NCT NCT02006888)

NCT ID: NCT02006888

Last Updated: 2018-04-23

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

394 participants

Primary outcome timeframe

Day 8

Results posted on

2018-04-23

Participant Flow

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

Participant milestones

Participant milestones
Measure	IBI-10090 Low Dose IBI-10090 low dose IBI-10090	IBI-10090 Med Dose IBI-10090 med dose IBI-10090	Placebo Placebo Placebo: Placebo
Overall Study STARTED	158	156	80
Overall Study COMPLETED	122	122	58
Overall Study NOT COMPLETED	36	34	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IBI-10090 Low Dose n=158 Participants IBI-10090 low dose IBI-10090	IBI-10090 Med Dose n=156 Participants IBI-10090 med dose IBI-10090	Placebo n=80 Participants Placebo Placebo: Placebo	Total n=394 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants	41 Participants n=7 Participants	17 Participants n=5 Participants	99 Participants n=4 Participants
Age, Categorical >=65 years	117 Participants n=5 Participants	115 Participants n=7 Participants	63 Participants n=5 Participants	295 Participants n=4 Participants
Age, Continuous	70 years STANDARD_DEVIATION 9 • n=5 Participants	70 years STANDARD_DEVIATION 9 • n=7 Participants	71 years STANDARD_DEVIATION 9 • n=5 Participants	70 years STANDARD_DEVIATION 9 • n=4 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	69 Participants n=7 Participants	39 Participants n=5 Participants	183 Participants n=4 Participants
Sex: Female, Male Male	83 Participants n=5 Participants	87 Participants n=7 Participants	41 Participants n=5 Participants	211 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants	23 Participants n=7 Participants	14 Participants n=5 Participants	56 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	139 Participants n=5 Participants	133 Participants n=7 Participants	66 Participants n=5 Participants	338 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	21 Participants n=7 Participants	11 Participants n=5 Participants	49 Participants n=4 Participants
Race (NIH/OMB) White	129 Participants n=5 Participants	123 Participants n=7 Participants	67 Participants n=5 Participants	319 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	7 Participants n=7 Participants	1 Participants n=5 Participants	13 Participants n=4 Participants
Region of Enrollment United States	158 participants n=5 Participants	156 participants n=7 Participants	80 participants n=5 Participants	394 participants n=4 Participants

PRIMARY outcome

Timeframe: Day 8

Outcome measures

Outcome measures
Measure	IBI-10090 Low Dose n=158 Participants IBI-10090 low dose IBI-10090	IBI-10090 Med Dose n=156 Participants IBI-10090 med dose IBI-10090	Placebo n=80 Participants Placebo Placebo: Placebo
Number of Participants With Anterior Chamber Cell Clearing	99 Participants	103 Participants	20 Participants

Adverse Events

IBI-10090 Low Dose

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

IBI-10090 Med Dose

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IBI-10090 Low Dose n=158 participants at risk IBI-10090 low dose IBI-10090	IBI-10090 Med Dose n=156 participants at risk IBI-10090 med dose IBI-10090	Placebo n=80 participants at risk Placebo Placebo: Placebo
Eye disorders Corneal decompensation	0.63% 1/158 • Number of events 1	0.00% 0/156	0.00% 0/80

Other adverse events

Other adverse events
Measure	IBI-10090 Low Dose n=158 participants at risk IBI-10090 low dose IBI-10090	IBI-10090 Med Dose n=156 participants at risk IBI-10090 med dose IBI-10090	Placebo n=80 participants at risk Placebo Placebo: Placebo
Eye disorders eye pain	10.1% 16/158 • Number of events 16	2.6% 4/156 • Number of events 4	8.8% 7/80 • Number of events 7

Additional Information

Howard Franklin

IconBioscience

Phone: 2153961332

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place