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The objective of this study is to assess the safety and efficacy of RGN-259 Ophthalmic Solution compared to placebo for the treatment of NK.
Neurotrophic keratopathy (NK) is a degenerative corneal disease that occurs as a result of partial or total impairment of trigeminal innervation. The resulting loss of corneal sensitivity (anesthesia) leads to a reduction in lacrimation and a decline in status, metabolism, and mitosis of corneal epithelial cells. Previous studies (physician-sponsored studies) used to treat to nine patients with NK, six of whom had discrete geographic, non-healing lesions, and three of whom had punctate lesions and the study result reported.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RGN-259 | Experimental | It is a preservative-free, sterile eye drop solution containing Tβ4 |
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| Placebo | Placebo Comparator | It is composed of the same excipients as RGN-259 but does not contain Tβ4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RGN-259 | Drug | A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into affected eye(s), five times a day for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving Complete Healing at Day 29. | Percentage of subjects achieving complete healing of the persistent epithelial defect as determined by corneal fluorescein staining at day 29 after first dosing. | 29 days after first dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days | Percentage of subjects achieving complete healing of the Persistent Epithelial Defect(PED) determined by corneal fluorescein staining at 8, 15, 22, 36, 43 days after first dosing. | 8, 15, 22, 36, 43 days after first dosing |
| Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With an Abnormal Findings by Slit-lamp Biomicroscopy at 8, 15, 22, 29, 36, 43 Days | The number of participants with a abnormal findings by Slit-lamp biomicroscopy at 8, 15, 22, 29, 36, 43 days This outcome was assessed by the number of participants with an abnormal findings which are clinically significant using slit-lamp biomicroscopy which provides a magnified view of intraocular structures in the Cornea, Conjunctiva, Anterior Chamber, Iris, Lens, Eyelid. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hull Eye Center | Lancaster | California | 93534 | United States | ||
| Vision Institute |
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Subjects were screened prior to randomization. And after confirmation of inclusion and exclusion criteria, all eligible subjects were randomized in a 2:1 ratio to receive 0.1% RGN-259 or placebo ophthalmic solution bilaterally, five times per day for 28 days. The study comprised of 7 visits over the course of approximately 6 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | RGN-259 | It is a preservative-free, sterile eye drop solution containing Tβ4 RGN-259: A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into affected eye(s), five times a day for 4 weeks. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 4, 2017 | Jul 20, 2023 |
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| Placebo | Drug | It is composed of the same excipients as RGN-259 but does not contain Tβ4 |
|
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Epithelial Defect Measurement and Classification as stage 1, 2 or 3 using Mackie Classification at 8, 15, 22, 29, 36, 43 days after first dosing |
| 8, 15, 22, 29, 36, 43 days after first dosing |
| Tear Film Break-up Time at 29, 36, 43 Days | Tear Film Break-up Time at 29, 36, 43 days after first dosing | 29, 36, 43 days after first dosing |
| Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing | Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing at Visits 2, 3, 4, 5, 6, and 7 (The scale used to determine the difference in Ocular Discomfort by questionnaire on each visit is from 0(None) to 5(Most). This outcome was calculated from two time points as the value at the later time point minus the value at the first dosing points and the lower value are considered to be a better outcome. and the all relevant time points used in the calculation in the Time Frame was 8, 15, 22, 29, 36, 43 days.) | 8, 15, 22, 29, 36, 43 days after first dosing |
| Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days | Visual acuity(logMAR) at 8, 15, 22, 29, 36, 43 days (The Visual acuity was assessed by LogMAR calculation method. In the case of the LogMAR method, Each letter has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units. and The lower value are considered to be a better outcome.) The formula used in calculating the score is: LogMAR VA = 0.1 + LogMAR value of the best line read - 0.02 X (number of optotypes read) used to determine the difference in Ocular Discomfort by questionnaire on each visit is the ORA scale: 0 None to 5: Most And as this outcome was calculated from two time points as the value at the later time point minus the value at the first dosing points, The lower value are considered to be a better outcome. and the all relevant time points used in the calculation in the Time Frame was 8, 15, 22, 29, 36, 43 days.) | 8, 15, 22, 29, 36, 43 days after first dosing |
| 8, 15, 22, 29, 36, 43 days after first dosing |
| Corneal Sensitivity Using the Aesthesiometer (Cochet-Bonnet) | Corneal Sensitivity using the aesthesiometer (Cochet-Bonnet) at 29, 43 days after first dosing | 29, 43 days after first dosing |
| The Number of Participants With an Abnormal Findings by Dilated Fundoscopy at 29, 43 Days | The number of participants with an abnormal findings by Dilated Fundoscopy at 29, 43 days This outcome was assessed by the number of participants with an abnormal findings which are clinically significant using Dilated Fundoscopy which is a diagnostic procedure to view the eye's interior, allowing assessment of the Vitreous, Retina, Macula, Choroid, and Optic Nerve. | 29, 43 days after first dosing |
| Intraocular Pressure | Intraocular Pressure at 29, 43 days after first dosing | 29, 43 days after first dosing |
| Colorado Springs |
| Colorado |
| 80907 |
| United States |
| Eye Center of Northern Colorado | Fort Collins | Colorado | 80525 | United States |
| Insight Vision Group | Parker | Colorado | 80134 | United States |
| Medical Faculty Associates, Inc. | Washington D.C. | District of Columbia | 20037 | United States |
| Midwest Cornea Associates, LLC | Indianapolis | Indiana | 46290 | United States |
| Koffler Vision Group | Lexington | Kentucky | 40509 | United States |
| Richard Eiferman, MD, PSC | Louisville | Kentucky | 40205 | United States |
| The Eye Care Institute | Louisville | Kentucky | 40206 | United States |
| Central Maine Eye Care | Lewiston | Maine | 04240 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
It is composed of the same excipients as RGN-259 but does not contain Tβ4. Placebo: It is composed of the same excipients as RGN-259 but does not contain Tβ4 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | RGN-259 | It is a preservative-free, sterile eye drop solution containing Tβ4 RGN-259: A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into affected eye(s), five times a day for 4 weeks. |
| BG001 | Placebo | It is composed of the same excipients as RGN-259 but does not contain Tβ4. Placebo: It is composed of the same excipients as RGN-259 but does not contain Tβ4 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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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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| 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 Subjects Achieving Complete Healing at Day 29. | Percentage of subjects achieving complete healing of the persistent epithelial defect as determined by corneal fluorescein staining at day 29 after first dosing. | Posted | Count of Participants | Participants | 29 days after first dosing |
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| Secondary | Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days | Percentage of subjects achieving complete healing of the Persistent Epithelial Defect(PED) determined by corneal fluorescein staining at 8, 15, 22, 36, 43 days after first dosing. | Posted | Count of Participants | Participants | 8, 15, 22, 36, 43 days after first dosing |
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| Secondary | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 1, 2 or 3 using Mackie Classification at 8, 15, 22, 29, 36, 43 days after first dosing | Posted | Number | participants | 8, 15, 22, 29, 36, 43 days after first dosing |
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| Secondary | Tear Film Break-up Time at 29, 36, 43 Days | Tear Film Break-up Time at 29, 36, 43 days after first dosing | Posted | Mean | Standard Deviation | Seconds | 29, 36, 43 days after first dosing |
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| Secondary | Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing | Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing at Visits 2, 3, 4, 5, 6, and 7 (The scale used to determine the difference in Ocular Discomfort by questionnaire on each visit is from 0(None) to 5(Most). This outcome was calculated from two time points as the value at the later time point minus the value at the first dosing points and the lower value are considered to be a better outcome. and the all relevant time points used in the calculation in the Time Frame was 8, 15, 22, 29, 36, 43 days.) | Posted | Mean | Standard Deviation | score on a scale | 8, 15, 22, 29, 36, 43 days after first dosing |
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| Secondary | Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days | Visual acuity(logMAR) at 8, 15, 22, 29, 36, 43 days (The Visual acuity was assessed by LogMAR calculation method. In the case of the LogMAR method, Each letter has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units. and The lower value are considered to be a better outcome.) The formula used in calculating the score is: LogMAR VA = 0.1 + LogMAR value of the best line read - 0.02 X (number of optotypes read) used to determine the difference in Ocular Discomfort by questionnaire on each visit is the ORA scale: 0 None to 5: Most And as this outcome was calculated from two time points as the value at the later time point minus the value at the first dosing points, The lower value are considered to be a better outcome. and the all relevant time points used in the calculation in the Time Frame was 8, 15, 22, 29, 36, 43 days.) | Posted | Mean | Standard Deviation | logMAR | 8, 15, 22, 29, 36, 43 days after first dosing |
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| Other Pre-specified | The Number of Participants With an Abnormal Findings by Slit-lamp Biomicroscopy at 8, 15, 22, 29, 36, 43 Days | The number of participants with a abnormal findings by Slit-lamp biomicroscopy at 8, 15, 22, 29, 36, 43 days This outcome was assessed by the number of participants with an abnormal findings which are clinically significant using slit-lamp biomicroscopy which provides a magnified view of intraocular structures in the Cornea, Conjunctiva, Anterior Chamber, Iris, Lens, Eyelid. | Posted | Number | participants | 8, 15, 22, 29, 36, 43 days after first dosing |
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| Other Pre-specified | Corneal Sensitivity Using the Aesthesiometer (Cochet-Bonnet) | Corneal Sensitivity using the aesthesiometer (Cochet-Bonnet) at 29, 43 days after first dosing | Posted | Mean | Standard Deviation | mm | 29, 43 days after first dosing |
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| Other Pre-specified | The Number of Participants With an Abnormal Findings by Dilated Fundoscopy at 29, 43 Days | The number of participants with an abnormal findings by Dilated Fundoscopy at 29, 43 days This outcome was assessed by the number of participants with an abnormal findings which are clinically significant using Dilated Fundoscopy which is a diagnostic procedure to view the eye's interior, allowing assessment of the Vitreous, Retina, Macula, Choroid, and Optic Nerve. | Posted | Number | participants | 29, 43 days after first dosing |
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| Other Pre-specified | Intraocular Pressure | Intraocular Pressure at 29, 43 days after first dosing | Posted | Mean | Standard Deviation | mmHg | 29, 43 days after first dosing |
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Adverse events were collected at every visit through study completion, approximately 6 weeks.
There was no anticipated/unanticipated deaths due to any cause in this study.
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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 | RGN-259 | It is a preservative-free, sterile eye drop solution containing Tβ4 RGN-259: A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into affected eye(s), five times a day for 4 weeks. | 0 | 10 | 1 | 10 | 4 | 10 |
| EG001 | Placebo | It is composed of the same excipients as RGN-259 but does not contain Tβ4. Placebo: It is composed of the same excipients as RGN-259 but does not contain Tβ4 | 0 | 8 | 0 | 8 | 3 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal epithelium defect | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Corneal opacity | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Keratic precipitates | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Vitreous detachment | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Inflammation | General disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Blood glucose decreased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| Unresponsive to stimuli | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Upper repiratory tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of clinical operation | clinical operation | swkang@regentreellc.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 10, 2019 | Jun 15, 2023 | SAP_001.pdf |
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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