Trial Outcomes & Findings for Efficacy and Safety of IBI-10090 in Ocular Surgery Patients (NCT NCT01606735)
NCT ID: NCT01606735
Last Updated: 2014-09-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
172 participants
Primary outcome timeframe
8 days post-treatment
Results posted on
2014-09-22
Participant Flow
Participant milestones
| Measure |
342 mcg
IBI-10090: dexamethasone
|
517 mcg
IBI-10090: dexamethasone
|
697 mcg
IBI-10090: dexamethasone
|
|---|---|---|---|
|
Overall Study
STARTED
|
58
|
56
|
58
|
|
Overall Study
COMPLETED
|
58
|
56
|
58
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of IBI-10090 in Ocular Surgery Patients
Baseline characteristics by cohort
| Measure |
342 mcg
n=58 Participants
IBI-10090: dexamethasone
|
517 mcg
n=56 Participants
IBI-10090: dexamethasone
|
697 mcg
n=58 Participants
IBI-10090: dexamethasone
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
71.8 years
STANDARD_DEVIATION 71.8 • n=7 Participants
|
70.1 years
STANDARD_DEVIATION 10 • n=5 Participants
|
70.1 years
STANDARD_DEVIATION 9.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
146 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
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
56 participants
n=7 Participants
|
58 participants
n=5 Participants
|
172 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 days post-treatmentThis 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.
Outcome measures
| Measure |
342 mcg
n=58 Participants
IBI-10090: dexamethasone
|
517 mcg
n=56 Participants
IBI-10090: dexamethasone
|
697 mcg
n=58 Participants
IBI-10090: dexamethasone
|
|---|---|---|---|
|
Anterior Chamber Cell Count at Day 8 Post-Treatment
|
50 percentage of patients with ACC clearing
Interval 37.13 to 62.87
|
51.8 percentage of patients with ACC clearing
Interval 38.7 to 64.87
|
60.3 percentage of patients with ACC clearing
Interval 47.76 to 72.93
|
Adverse Events
342 mcg
Serious events: 6 serious events
Other events: 2 other events
Deaths: 0 deaths
517 mcg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
697 mcg
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
342 mcg
n=58 participants at risk
IBI-10090: dexamethasone
|
517 mcg
n=56 participants at risk
IBI-10090: dexamethasone
|
697 mcg
n=58 participants at risk
IBI-10090: dexamethasone
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
1.7%
1/58
|
0.00%
0/56
|
0.00%
0/58
|
|
Eye disorders
Corneal edema
|
3.4%
2/58
|
0.00%
0/56
|
0.00%
0/58
|
|
Eye disorders
Corneal endothelial cell loss
|
5.2%
3/58
|
1.8%
1/56
|
5.2%
3/58
|
|
Eye disorders
Endophthalmitis
|
1.7%
1/58
|
0.00%
0/56
|
0.00%
0/58
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
0.00%
0/58
|
1.8%
1/56
|
0.00%
0/58
|
Other adverse events
| Measure |
342 mcg
n=58 participants at risk
IBI-10090: dexamethasone
|
517 mcg
n=56 participants at risk
IBI-10090: dexamethasone
|
697 mcg
n=58 participants at risk
IBI-10090: dexamethasone
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
3.4%
2/58
|
0.00%
0/56
|
1.7%
1/58
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/58
|
3.6%
2/56
|
0.00%
0/58
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER