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Efficacy and Safety of IBI-10090 in Ocular Surgery Patients

A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Ocular Surgery

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01606735
Enrollment
172
Registered
2012-05-28
Start date
2012-04-30
Completion date
2013-03-31
Last updated
2014-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation Associated With Cataract Surgery

Keywords

cataract surgery, ocular inflammation

Brief summary

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

Interventions

DRUGIBI-10090

dexamethasone

Sponsors

ICON Bioscience Inc
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients scheduled for unilateral cataract surgery

Exclusion criteria

* Ocular, topical, or oral corticosteroids within 7 days of Day 0

Design outcomes

Primary

MeasureTime frameDescription
Anterior Chamber Cell Count at Day 8 Post-Treatment8 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
342 mcg
IBI-10090: dexamethasone
58
517 mcg
IBI-10090: dexamethasone
56
697 mcg
IBI-10090: dexamethasone
58
Total172

Baseline characteristics

Characteristic342 mcgTotal697 mcg517 mcg
Age, Continuous68 years
STANDARD_DEVIATION 8.9
70.1 years
STANDARD_DEVIATION 9.2
70.1 years
STANDARD_DEVIATION 10
71.8 years
STANDARD_DEVIATION 71.8
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants3 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
2 Participants10 Participants6 Participants2 Participants
Race (NIH/OMB)
Black or African American
1 Participants7 Participants5 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants5 Participants1 Participants1 Participants
Race (NIH/OMB)
White
50 Participants146 Participants45 Participants51 Participants
Region of Enrollment
United States
58 participants172 participants58 participants56 participants
Sex: Female, Male
Female
35 Participants105 Participants31 Participants39 Participants
Sex: Female, Male
Male
23 Participants67 Participants27 Participants17 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
2 / 582 / 561 / 58
serious
Total, serious adverse events
6 / 582 / 563 / 58

Outcome results

Primary

Anterior Chamber Cell Count at Day 8 Post-Treatment

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.

Time frame: 8 days post-treatment

ArmMeasureValue (NUMBER)
342 mcgAnterior Chamber Cell Count at Day 8 Post-Treatment50 percentage of patients with ACC clearing
517 mcgAnterior Chamber Cell Count at Day 8 Post-Treatment51.8 percentage of patients with ACC clearing
697 mcgAnterior Chamber Cell Count at Day 8 Post-Treatment60.3 percentage of patients with ACC clearing

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026