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NDA #210565 did not trigger the need for a Pediatric Research Equity Act study.
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This study is designed to assess how KPI-121 1% compares to prednisolone acetate in reducing inflammation after cataract surgery in young children. Approximately half the participants will receive KPI-121 1% eye drops and the other half will receive prednisolone acetate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KPI-121 1% BID (twice daily) | Experimental |
| |
| Prednisolone acetate QID (four times daily) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KPI-121 1% | Drug | eye drops |
| |
| Prednisolone acetate |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior Chamber Cell Grade | Anterior chamber cell grading is a way of quantifying the amount of inflammation in inflammatory eye processes. Higher values indicate greater inflammation. The anterior chamber cell grading uses whole numbers from 0 (no cells) to 4 (> 30 cells) as follows: Anterior chamber cell grade 0 = no cells seen Anterior chamber cell grade 1 = 1 - 5 cells Anterior chamber cell grade 2 = 6 - 15 cells Anterior chamber cell grade 4 = greater than 30 cells | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Global Overall Assessment of Postoperative Inflammation | The Modified Global Overall Assessment is a way of quantifying the amount of post operative healing that has occurred. Lower values indicate greater healing.The Modified Global Assessment grading uses whole numbers from 0 (clear) to 2 (not improving or worsening) as follows: 0 = clear
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byers Eye Institute at Stanford University | Palo Alto | California | 94303 | United States | ||
| Children's Eye Care, PC |
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| ID | Title | Description |
|---|---|---|
| FG000 | KPI-121 1% BID (Twice Daily) | Subjects randomized to KPI-121 1% eye drops |
| FG001 | Prednisolone Acetate QID (Four Times Daily) | Subjects randomized to Prednisolone acetate eye drops |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | KPI-121 1% BID (Twice Daily) | KPI-121 1%: eye drops |
| BG001 | Prednisolone Acetate QID (Four Times Daily) | Prednisolone acetate: eye drops |
| 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 Grade | Anterior chamber cell grading is a way of quantifying the amount of inflammation in inflammatory eye processes. Higher values indicate greater inflammation. The anterior chamber cell grading uses whole numbers from 0 (no cells) to 4 (> 30 cells) as follows: Anterior chamber cell grade 0 = no cells seen Anterior chamber cell grade 1 = 1 - 5 cells Anterior chamber cell grade 2 = 6 - 15 cells Anterior chamber cell grade 4 = greater than 30 cells | Posted | Count of Participants | Participants | Day 15 |
|
Adverse events were collected from first dose of Investigational Product use at Visit 2 through conclusion of Visit 6, approximately 36 days.
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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 | KPI-121 1% BID | KPI-121 1%: eye drops | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suture Related Complication | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
Due to stopping the study after just two subjects were enrolled, no meaningful conclusions could be reached.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical Development | Kala Pharmaceuticals, Inc | 781-996-5252 | Results010@kalarx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2018 | Sep 21, 2020 | Prot_SAP_003.pdf |
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| ID | Term |
|---|---|
| C009935 | prednisolone acetate |
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| Drug |
eye drops |
|
|
| Day 15 |
| Detroit |
| Michigan |
| 48201 |
| United States |
| Pediatric Ophthalmology of Erie, Inc. | Erie | Pennsylvania | 16501 | United States |
| Houston Eye Associates | The Woodlands | Texas | 77380 | United States |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Study Eye OD (right eye) | Number | participants |
|
| Study Eye OS (left eye) | Count of Participants | Participants |
|
|
|
| Secondary | Modified Global Overall Assessment of Postoperative Inflammation | The Modified Global Overall Assessment is a way of quantifying the amount of post operative healing that has occurred. Lower values indicate greater healing.The Modified Global Assessment grading uses whole numbers from 0 (clear) to 2 (not improving or worsening) as follows: 0 = clear
| Posted | Count of Participants | Participants | Day 15 |
|
|
|
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Prednisolone Acetate QID | Prednisolone acetate: eye drops | 0 | 1 | 0 | 1 | 1 | 1 |
| Increased Ocular Inflammation | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Otitis Media | Ear and labyrinth disorders | MedDRA 21.0 | Non-systematic Assessment |
|
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| Modified Global Overall Assessment = 2 |
|