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This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after ocular surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental |
| |
| Dose 2 | Experimental |
| |
| Dose 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI-10090 | Drug | dexamethasone |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 days post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy Murahashi, MD | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inland Eye Specialists | Hemet | California | 92545 | United States | ||
| California Eye Professionals |
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| ID | Title | Description |
|---|---|---|
| FG000 | 342 mcg | IBI-10090: dexamethasone |
| FG001 | 517 mcg | IBI-10090: dexamethasone |
| FG002 | 697 mcg | IBI-10090: dexamethasone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 342 mcg | IBI-10090: dexamethasone |
| BG001 | 517 mcg | IBI-10090: dexamethasone |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number | 95% Confidence Interval | percentage of patients with ACC clearing | 8 days post-treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 342 mcg | IBI-10090: dexamethasone |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Murahashi, MD | Icon Bioscience, Inc | 6503694049 | wendymurahashi@iconbioscience.com |
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| Temecula |
| California |
| 92591 |
| United States |
| 697 mcg |
IBI-10090: dexamethasone |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
IBI-10090: dexamethasone
|
|
| 6 |
| 58 |
| 2 |
| 58 |
| EG001 | 517 mcg | IBI-10090: dexamethasone | 2 | 56 | 2 | 56 |
| EG002 | 697 mcg | IBI-10090: dexamethasone | 3 | 58 | 1 | 58 |
| Corneal edema | Eye disorders |
|
| Corneal endothelial cell loss | Eye disorders |
|
| Endophthalmitis | Eye disorders |
|
| Influenza | Respiratory, thoracic and mediastinal disorders |
|
| Dry Skin | Skin and subcutaneous tissue disorders |
|
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.