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The objective of this study is to evaluate the safety and effectiveness of topical KIO-201 in patients with persistent corneal epithelial defects (PED). KIO-201 will be administered six (6) times per day while awake for 4 weeks.
The primary exploratory effectiveness outcome for this study is the percentage of patients achieving corneal healing as determined by corneal fluorescein staining and photos. The effectiveness endpoint will be evaluated by a reader using digital photography of fluorescein stained slit lamp photos and image analysis.
This is a prospective, exploratory study in which up to 10 patients (up to 20 eyes [minimum of 10 eyes]) diagnosed with Stage 1 and Stage 2 PED (as defined by fluorescein staining of the cornea and refractory to one or more conventional non-surgical treatments of at least 2 weeks) will receive KIO-201 with a dosing regimen of six (6) times per day over 4 weeks.
Both eyes are to be included if both eyes meet inclusion criteria and both eyes will be treated with KIO-201.
Patients will followed for a 4 week study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm active | Experimental | KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S), up to 6 times a day for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S) | Drug | KIO-201 is a stand-alone drug therapy that acts as a barrier that minimizes mechanical lid friction and mechanically protects the ocular surface thereby reducing repeat injury and providing an environment that enables the body to repair the ocular surface whether the corneal epithelial defects are large or small. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving Corneal Healing (<0.5 mm2 Lesion Size) of the Persistent Corneal Epithelial Defect at 4 Weeks | Determined by corneal fluorescein staining and the effectiveness endpoint will also be evaluated by a reader using digital photography of fluorescein stained slit lamp photos and image analysis. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enrique Graue, M.D. | Instituto de OftalmologÃa Fundación Conde de Valenciana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de OftalmologÃa Fundación Conde de Valenciana | Mexico City | Chimalpopoca 14 Colonia Obrera | 06800 | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Active | KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S), up to 6 times a day for 4 weeks. KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S): KIO-201 is a stand-alone drug therapy that acts as a barrier that minimizes mechanical lid friction and mechanically protects the ocular surface thereby reducing repeat injury and providing an environment that enables the body to repair the ocular surface whether the corneal epithelial defects are large or small. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Active | KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S), up to 6 times a day for 4 weeks. KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S): KIO-201 is a stand-alone drug therapy that acts as a barrier that minimizes mechanical lid friction and mechanically protects the ocular surface thereby reducing repeat injury and providing an environment that enables the body to repair the ocular surface whether the corneal epithelial defects are large or small. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percentage of Patients Achieving Corneal Healing (<0.5 mm2 Lesion Size) of the Persistent Corneal Epithelial Defect at 4 Weeks | Determined by corneal fluorescein staining and the effectiveness endpoint will also be evaluated by a reader using digital photography of fluorescein stained slit lamp photos and image analysis. | Eight (8) eyes were evaluable Five (5) of 8 (62.5%) of the evaluable participants achieved the primary endpoint of healing (<0.5 mm2 lesion size) at the 4-week period | Posted | Count of Participants | Participants | 4 weeks |
|
4 weeks
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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 | Single Arm Active | KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S), up to 6 times a day for 4 weeks. KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S): KIO-201 is a stand-alone drug therapy that acts as a barrier that minimizes mechanical lid friction and mechanically protects the ocular surface thereby reducing repeat injury and providing an environment that enables the body to repair the ocular surface whether the corneal epithelial defects are large or small. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Discomfort | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Daniels | Kiora Pharmaceuticals, Inc. | 858-353-0469 | edaniels@kiorapharma.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 2, 2022 | Feb 21, 2024 | Prot_000.pdf |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 |
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| 0 |
| 10 |
| 0 |
| 10 |
| 4 |
| 10 |
| Change in Vision | Eye disorders | Systematic Assessment |
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