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Study was terminated in order to examine study data.
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This study will test the efficacy and safety of IBI-10090 for the reduction of ocular inflammation after cataract surgery.
All patients received active treatment in this study. Dose group 1 received 114ug of dexamethasone, Dose group 2 received 513ug and Dose group 3 received 684ug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental | 114ug |
|
| Dose 2 | Experimental | 513ug |
|
| Dose 3 | Experimental | 684ug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI-10090 | Drug | Single intraocular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clearance of Anterior Chamber Cells | Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber cells (ACC) graded on a scale of 0 to 4. The primary efficacy endpoint was complete clearing of ACC, where grade 0 = 0 cells in the anterior chamber on POD 8. | Day 8 post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior Chamber Flare (ACF) Grade | Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber flare (ACF) graded on a scale of 0 to 4. | Day 90 post-treatment |
| Conjunctival Erythema Grade |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Chang, MD | Altos Eye Physicians | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altos Eye Physicians | Los Altos | California | 94024 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose 1 | 114ug dose group |
| FG001 | Dose 2 | 513ug dose group |
| FG002 | Dose 3 | 684ug dose group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose 1 | 114ug dose group |
| BG001 | Dose 2 | 513ug dose group |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Clearance of Anterior Chamber Cells | Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber cells (ACC) graded on a scale of 0 to 4. The primary efficacy endpoint was complete clearing of ACC, where grade 0 = 0 cells in the anterior chamber on POD 8. | Posted | Count of Participants | Participants | Day 8 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 | Dose 1 | 114ug dose group |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasopharyngitis | General disorders | Systematic Assessment |
Early termination leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulatory Affairs Specialist | Eyepoint Pharmaceuticals, Inc. | 6179726318 | dbauer@eyepointpharma.com |
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Conjunctival erythema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.
| Day 90 post-treatment |
| Corneal Edema Grade | Cornea edema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3. | Day 90 post-treatment |
| Anterior Chamber Cell Grade | Anterior chamber cells (ACC) grade was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 4. | Day 90 post-treatment |
| Dose 3 |
684ug dose group |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex/Gender, Customized | The number of male/female per treatment group was not recorded. | Number | participants |
|
684ug IBI-10090: Single intraocular injection |
|
|
| Secondary | Anterior Chamber Flare (ACF) Grade | Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber flare (ACF) graded on a scale of 0 to 4. | Posted | Count of Participants | Participants | Day 90 post-treatment |
|
|
|
| Secondary | Conjunctival Erythema Grade | Conjunctival erythema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3. | Posted | Count of Participants | Participants | Day 90 post-treatment |
|
|
|
| Secondary | Corneal Edema Grade | Cornea edema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3. | Posted | Count of Participants | Participants | Day 90 post-treatment |
|
|
|
| Secondary | Anterior Chamber Cell Grade | Anterior chamber cells (ACC) grade was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 4. | Posted | Count of Participants | Participants | Day 90 post-treatment |
|
|
|
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | Dose 2 | 513ug dose group | 0 | 2 | 1 | 2 |
| EG002 | Dose 3 | 684ug dose group | 0 | 1 | 1 | 1 |
| myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| skin infection | General disorders | Systematic Assessment |
|
| rash | General disorders | Systematic Assessment |
|
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| Grade 2 (6-15 cells) |
|
| Grade 3 (16-30 cells) |
|
| Grade 4 (hypopyon) |
|
| Grade 2 (mild intensity) |
|
| Grade 3 (moderate Intensity) |
|
| Grade 4 (strong intensity) |
|
| POD 1 |
|
| POD 3 |
|
| POD 8 |
|
| POD 15 |
|
| POD 30 |
|
| POD 90 |
|
| Grade 2 (red bulbar) |
|
| Grade 3 (bright red bulbar) |
|
| POD 1 |
|
| POD 3 |
|
| POD 8 |
|
| POD 15 |
|
| POD 30 |
|
| POD 90 |
|
| Grade 2 (moderate edema) |
|
| Grade 3 (severe edema) |
|
| POD 1 |
|
| POD 3 |
|
| POD 8 |
|
| POD 15 |
|
| POD 30 |
|
| POD 90 |
|
| Grade 2 (6-15 cells) |
|
| Grade 3 (16-30 cells) |
|
| Grade 4 (hypopyon) |
|
| POD 1 |
|
| POD 3 |
|
| POD 8 |
|
| POD 15 |
|
| POD 30 |
|
| POD 90 |
|