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

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ClinicalTrials.gov Identifier: NCT02006888
Recruitment Status : Completed
First Posted : December 10, 2013
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
ICON Bioscience Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Inflammation
Cataracts
Interventions Drug: IBI-10090
Drug: Placebo
Enrollment 394
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.
Pre-assignment Details  
Arm/Group Title IBI-10090 Low Dose IBI-10090 Med Dose Placebo
Hide 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
Arm/Group Title IBI-10090 Low Dose IBI-10090 Med Dose Placebo Total
Hide Arm/Group Description

IBI-10090 low dose

IBI-10090

IBI-10090 med dose

IBI-10090

Placebo

Placebo: Placebo

Total of all reporting groups
Overall Number of Baseline Participants 158 156 80 394
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants 156 participants 80 participants 394 participants
<=18 years 0 0 0 0
Between 18 and 65 years 41 41 17 99
>=65 years 117 115 63 295
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 158 participants 156 participants 80 participants 394 participants
70  (9) 70  (9) 71  (9) 70  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants 156 participants 80 participants 394 participants
Female
75
  47.5%
69
  44.2%
39
  48.8%
183
  46.4%
Male
83
  52.5%
87
  55.8%
41
  51.2%
211
  53.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants 156 participants 80 participants 394 participants
Hispanic or Latino
19
  12.0%
23
  14.7%
14
  17.5%
56
  14.2%
Not Hispanic or Latino
139
  88.0%
133
  85.3%
66
  82.5%
338
  85.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants 156 participants 80 participants 394 participants
American Indian or Alaska Native
1
   0.6%
3
   1.9%
0
   0.0%
4
   1.0%
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
   0.0%
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
  81.0%
More than one race
0
   0.0%
0
   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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 158 participants 156 participants 80 participants 394 participants
158 156 80 394
1.Primary Outcome
Title Number of Participants With Anterior Chamber Cell Clearing
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IBI-10090 Low Dose IBI-10090 Med Dose Placebo
Hide Arm/Group Description:

IBI-10090 low dose

IBI-10090

IBI-10090 med dose

IBI-10090

Placebo

Placebo: Placebo

Overall Number of Participants Analyzed 158 156 80
Measure Type: Count of Participants
Unit of Measure: Participants
99
  62.7%
103
  66.0%
20
  25.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IBI-10090 Low Dose IBI-10090 Med Dose Placebo
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/158 (0.00%)      0/156 (0.00%)      0/80 (0.00%)    
Show Serious Adverse Events Hide 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 (0.63%)      0/156 (0.00%)      0/80 (0.00%)    
Eye disorders       
Corneal decompensation  1  1/158 (0.63%)  1 0/156 (0.00%)  0 0/80 (0.00%)  0
1
Term from vocabulary, Corneal decompensati
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.5%
IBI-10090 Low Dose IBI-10090 Med Dose Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/158 (10.13%)      4/156 (2.56%)      7/80 (8.75%)    
Eye disorders       
eye pain  1  16/158 (10.13%)  16 4/156 (2.56%)  4 7/80 (8.75%)  7
1
Term from vocabulary, eye pain
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Howard Franklin
Organization: IconBioscience
Phone: 2153961332 ext 215
Responsible Party: ICON Bioscience Inc
ClinicalTrials.gov Identifier: NCT02006888     History of Changes
Other Study ID Numbers: C13-04
First Submitted: December 5, 2013
First Posted: December 10, 2013
Results First Submitted: August 15, 2017
Results First Posted: April 23, 2018
Last Update Posted: April 23, 2018