Ocular Inflammation
Conditions
Keywords
cataract, inflammation
Brief summary
This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after cataract surgery.
Interventions
DRUGIBI-10090
Sponsors
ICON Bioscience Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients 40 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation.
Exclusion criteria
* Patients who have used any ocular, topical, or oral corticosteroids within 7 days prior to Day 0. * Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to screening. * Patients with any signs of intraocular inflammation in either eye at screening. * Patients who have received any prior intravitreal injections in the study eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment | 8 days post-treatment | This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment in the study eye. The proportion of patients with anterior chamber cell count = 0 at Day 8 in the study eye for each dosage group will be compared. Only one eye was treated per participant. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dose 1 IBI-10090 513ug | 13 |
| Dose 2 IBI-10090 776ug | 16 |
| Dose 3 IBI-10090 1046ug | 13 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Dose 2 | Dose 3 | Dose 1 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 11 Participants | 11 Participants | 35 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 2 Participants | 7 Participants |
| Age Continuous | 72.4 years STANDARD_DEVIATION 8.9 | 73.5 years STANDARD_DEVIATION 7.2 | 70.9 years STANDARD_DEVIATION 5.5 | 72.3 years STANDARD_DEVIATION 7.4 |
| Region of Enrollment United States | 16 participants | 13 participants | 13 participants | 42 participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 4 Participants | 17 Participants |
| Sex: Female, Male Male | 10 Participants | 6 Participants | 9 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 13 | 13 / 16 | 13 / 13 |
| serious Total, serious adverse events | 0 / 13 | 1 / 16 | 3 / 13 |
Outcome results
Primary
Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment
This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment in the study eye. The proportion of patients with anterior chamber cell count = 0 at Day 8 in the study eye for each dosage group will be compared. Only one eye was treated per participant.
Time frame: 8 days post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dose 1 | Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment | 30.8 percentage of patients with ACC clearing |
| Dose 2 | Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment | 25 percentage of patients with ACC clearing |
| Dose 3 | Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment | 46.2 percentage of patients with ACC clearing |