Neurotrophic Keratopathy
Conditions
Keywords
Neurotrophic Keratopathy, NK
Brief summary
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.
Detailed description
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.
Interventions
DRUGRGN-259
A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into affected eye(s), five times a day for 4 weeks.
DRUGPlacebo
It is composed of the same excipients as RGN-259 but does not contain Tβ4
Sponsors
ReGenTree, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be male or female of any race, at least 18 years of age * Have provided verbal and written informed consent. * Be able and willing to follow instructions, including participation in all study assessments and visits; * Have stage 2 or 3 neurotrophic keratopathy in at least one eye If a female of childbearing potential, have a negative urine pregnancy test at Visit 1 and agree to use an adequate method of birth control throughout the study period.
Exclusion criteria
* Have any clinically significant slit lamp findings at Visit 1 that in the opinion of the investigator may interfere with the study parameters; * Have significant blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergy that requires treatment * Have a lid function abnormality (ex. Lagophthalmos) which, in the opinion of the investigator, is the primary cause of the persistent epithelial defect; * Be diagnosed with ongoing ocular infection (bacterial, viral or fungal) or active inflammation (e.g. follicular conjunctivitis) not related to NK * Anticipate the use of fluoroquinolone-containing antibiotic eye drops during the study; * Have used contact lenses (excluding therapeutic contact lenses) within 14 days prior to Visit 1 or anticipates use of contact lenses during the study period; * Have an uncontrolled systemic disease that in the opinion of the investigator may interfere with the study parameters; * Anticipate a change in immunosuppressive therapy during the course of the study;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Achieving Complete Healing at Day 29. | 29 days after first dosing | Percentage of subjects achieving complete healing of the persistent epithelial defect as determined by corneal fluorescein staining at day 29 after first dosing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | 8, 15, 22, 29, 36, 43 days after first dosing | 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 |
| Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days | 8, 15, 22, 36, 43 days after first dosing | 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. |
| Tear Film Break-up Time at 29, 36, 43 Days | 29, 36, 43 days after first dosing | Tear Film Break-up Time at 29, 36, 43 days after first dosing |
| Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing | 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.) |
| Visual Acuity(logMAR) at 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 (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.) |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With an Abnormal Findings by Dilated Fundoscopy at 29, 43 Days | 29, 43 days after first dosing | 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. |
| Intraocular Pressure | 29, 43 days after first dosing | Intraocular Pressure at 29, 43 days after first dosing |
| Corneal Sensitivity Using the Aesthesiometer (Cochet-Bonnet) | 29, 43 days after first dosing | Corneal Sensitivity using the aesthesiometer (Cochet-Bonnet) at 29, 43 days after first dosing |
| The Number of Participants With an Abnormal Findings by Slit-lamp Biomicroscopy at 8, 15, 22, 29, 36, 43 Days | 8, 15, 22, 29, 36, 43 days after first dosing | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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 | 8 |
| Total | 18 |
Baseline characteristics
| Characteristic | RGN-259 | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 8 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 0 Participants | 7 Participants |
| Age, Continuous | 63.7 years STANDARD_DEVIATION 15.58 | 72.5 years STANDARD_DEVIATION 7.87 | 67.6 years STANDARD_DEVIATION 13.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 7 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 6 Participants | 16 Participants |
| Sex: Female, Male Female | 8 Participants | 4 Participants | 12 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 8 |
| other Total, other adverse events | 4 / 10 | 3 / 8 |
| serious Total, serious adverse events | 1 / 10 | 0 / 8 |
Outcome results
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.
Time frame: 29 days after first dosing
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RGN-259 | Percentage of Subjects Achieving Complete Healing at Day 29. | 6 Participants |
| Placebo | Percentage of Subjects Achieving Complete Healing at Day 29. | 1 Participants |
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
Time frame: 8, 15, 22, 29, 36, 43 days after first dosing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RGN-259 | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 2 at 8 days after first dosing | 8 participants |
| RGN-259 | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 1 at 22 days after first dosing | 6 participants |
| RGN-259 | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 2 at 36 days after first dosing | 3 participants |
| RGN-259 | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 2 at 22 days after first dosing | 3 participants |
| RGN-259 | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 3 at 8 days after first dosing | 1 participants |
| RGN-259 | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 3 at 22 days after first dosing | 0 participants |
| RGN-259 | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 1 at 29 days after first dosing | 6 participants |
| RGN-259 | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 2 at 29 days after first dosing | 2 participants |
| RGN-259 | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 1 at 15 days after first dosing | 4 participants |
| RGN-259 | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 3 at 29 days after first dosing | 0 participants |
| RGN-259 | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 1 at 8 days after first dosing | 1 participants |
| RGN-259 | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 1 at 36 days after first dosing | 5 participants |
| RGN-259 | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 2 at 15 days after first dosing | 5 participants |
| RGN-259 | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 1 at 43 days after first dosing | 4 participants |
| RGN-259 | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 3 at 36 days after first dosing | 0 participants |
| RGN-259 | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 2 at 43 days after first dosing | 3 participants |
| RGN-259 | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 3 at 15 days after first dosing | 0 participants |
| RGN-259 | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 3 at 43 days after first dosing | 0 participants |
| Placebo | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 3 at 15 days after first dosing | 0 participants |
| Placebo | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 2 at 36 days after first dosing | 6 participants |
| Placebo | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 3 at 36 days after first dosing | 1 participants |
| Placebo | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 3 at 43 days after first dosing | 0 participants |
| Placebo | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 1 at 8 days after first dosing | 2 participants |
| Placebo | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 2 at 8 days after first dosing | 6 participants |
| Placebo | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 3 at 8 days after first dosing | 0 participants |
| Placebo | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 1 at 15 days after first dosing | 3 participants |
| Placebo | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 2 at 15 days after first dosing | 5 participants |
| Placebo | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 3 at 22 days after first dosing | 0 participants |
| Placebo | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 1 at 22 days after first dosing | 3 participants |
| Placebo | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 2 at 22 days after first dosing | 5 participants |
| Placebo | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 1 at 29 days after first dosing | 2 participants |
| Placebo | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 2 at 29 days after first dosing | 6 participants |
| Placebo | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 3 at 29 days after first dosing | 0 participants |
| Placebo | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 1 at 36 days after first dosing | 1 participants |
| Placebo | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 1 at 43 days after first dosing | 1 participants |
| Placebo | Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification. | Epithelial Defect Measurement and Classification as stage 2 at 43 days after first dosing | 7 participants |
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.)
Time frame: 8, 15, 22, 29, 36, 43 days after first dosing
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RGN-259 | Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing | Ocular Discomfort by Questionnaire at 15 days after first dosing at Visits 3 | -1.8 score on a scale | Standard Deviation 0.79 |
| RGN-259 | Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing | Ocular Discomfort by Questionnaire at 29 days after first dosing at Visits 5 | -2.0 score on a scale | Standard Deviation 1.05 |
| RGN-259 | Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing | Ocular Discomfort by Questionnaire at 8 days after first dosing at Visits 2 | -1.5 score on a scale | Standard Deviation 0.97 |
| RGN-259 | Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing | Ocular Discomfort by Questionnaire at36 days after first dosing at Visits 6 | -1.4 score on a scale | Standard Deviation 1.43 |
| RGN-259 | Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing | Ocular Discomfort by Questionnaire at 43 days after first dosing at Visits 7 | -1.4 score on a scale | Standard Deviation 1.26 |
| RGN-259 | Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing | Ocular Discomfort by Questionnaire at 22 days after first dosing at Visits 4 | -1.7 score on a scale | Standard Deviation 1.06 |
| Placebo | Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing | Ocular Discomfort by Questionnaire at 43 days after first dosing at Visits 7 | -0.3 score on a scale | Standard Deviation 1.28 |
| Placebo | Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing | Ocular Discomfort by Questionnaire at 8 days after first dosing at Visits 2 | -0.6 score on a scale | Standard Deviation 1.19 |
| Placebo | Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing | Ocular Discomfort by Questionnaire at 15 days after first dosing at Visits 3 | -0.3 score on a scale | Standard Deviation 1.04 |
| Placebo | Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing | Ocular Discomfort by Questionnaire at 22 days after first dosing at Visits 4 | -0.4 score on a scale | Standard Deviation 0.92 |
| Placebo | Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing | Ocular Discomfort by Questionnaire at 29 days after first dosing at Visits 5 | -0.3 score on a scale | Standard Deviation 1.04 |
| Placebo | Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing | Ocular Discomfort by Questionnaire at36 days after first dosing at Visits 6 | -0.1 score on a scale | Standard Deviation 0.99 |
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.
Time frame: 8, 15, 22, 36, 43 days after first dosing
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RGN-259 | Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days | Percentage of subjects achieving complete healing of the PED at 8 days after first dosing. | 0 Participants |
| RGN-259 | Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days | Percentage of subjects achieving complete healing of the PED at 22 days | 4 Participants |
| RGN-259 | Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days | Percentage of subjects achieving complete healing of the PED at 15 days | 3 Participants |
| RGN-259 | Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days | Percentage of subjects achieving complete healing of the PED at 43 days | 5 Participants |
| RGN-259 | Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days | Percentage of subjects achieving complete healing of the PED at 36 days | 4 Participants |
| Placebo | Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days | Percentage of subjects achieving complete healing of the PED at 43 days | 0 Participants |
| Placebo | Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days | Percentage of subjects achieving complete healing of the PED at 36 days | 1 Participants |
| Placebo | Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days | Percentage of subjects achieving complete healing of the PED at 8 days after first dosing. | 0 Participants |
| Placebo | Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days | Percentage of subjects achieving complete healing of the PED at 15 days | 1 Participants |
| Placebo | Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days | Percentage of subjects achieving complete healing of the PED at 22 days | 2 Participants |
Secondary
Tear Film Break-up Time at 29, 36, 43 Days
Tear Film Break-up Time at 29, 36, 43 days after first dosing
Time frame: 29, 36, 43 days after first dosing
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RGN-259 | Tear Film Break-up Time at 29, 36, 43 Days | Tear Film Break-up Time at 29 days after first dosing | 4.444 Seconds | Standard Deviation 3.3215 |
| RGN-259 | Tear Film Break-up Time at 29, 36, 43 Days | Tear Film Break-up Time at 36 days after first dosing | 4.131 Seconds | Standard Deviation 3.0701 |
| RGN-259 | Tear Film Break-up Time at 29, 36, 43 Days | Tear Film Break-up Time at 43 days after first dosing | 6.217 Seconds | Standard Deviation 6.7617 |
| Placebo | Tear Film Break-up Time at 29, 36, 43 Days | Tear Film Break-up Time at 29 days after first dosing | 4.018 Seconds | Standard Deviation 2.8758 |
| Placebo | Tear Film Break-up Time at 29, 36, 43 Days | Tear Film Break-up Time at 36 days after first dosing | 3.658 Seconds | Standard Deviation 2.4115 |
| Placebo | Tear Film Break-up Time at 29, 36, 43 Days | Tear Film Break-up Time at 43 days after first dosing | 3.889 Seconds | Standard Deviation 2.1701 |
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.)
Time frame: 8, 15, 22, 29, 36, 43 days after first dosing
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RGN-259 | Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days | Visual acuity(logMAR) at 8 days | 1.451 logMAR | Standard Deviation 1.1873 |
| RGN-259 | Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days | Visual acuity(logMAR) at 15 days | 1.370 logMAR | Standard Deviation 1.3068 |
| RGN-259 | Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days | Visual acuity(logMAR) at 22 days | 1.287 logMAR | Standard Deviation 1.3616 |
| RGN-259 | Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days | Visual acuity(logMAR) at 29 days | 1.323 logMAR | Standard Deviation 1.3283 |
| RGN-259 | Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days | Visual acuity(logMAR) at 36 days | 1.280 logMAR | Standard Deviation 1.3542 |
| RGN-259 | Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days | Visual acuity(logMAR) at 43 days | 1.424 logMAR | Standard Deviation 1.4556 |
| Placebo | Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days | Visual acuity(logMAR) at 36 days | 0.990 logMAR | Standard Deviation 1.0315 |
| Placebo | Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days | Visual acuity(logMAR) at 8 days | 1.090 logMAR | Standard Deviation 0.9697 |
| Placebo | Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days | Visual acuity(logMAR) at 29 days | 1.003 logMAR | Standard Deviation 1.0315 |
| Placebo | Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days | Visual acuity(logMAR) at 15 days | 1.017 logMAR | Standard Deviation 1.0184 |
| Placebo | Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days | Visual acuity(logMAR) at 43 days | 0.997 logMAR | Standard Deviation 1.0292 |
| Placebo | Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days | Visual acuity(logMAR) at 22 days | 1.020 logMAR | Standard Deviation 1.0097 |
Other Pre-specified
Corneal Sensitivity Using the Aesthesiometer (Cochet-Bonnet)
Corneal Sensitivity using the aesthesiometer (Cochet-Bonnet) at 29, 43 days after first dosing
Time frame: 29, 43 days after first dosing
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RGN-259 | Corneal Sensitivity Using the Aesthesiometer (Cochet-Bonnet) | Corneal Sensitivity in Study Eye at 29 days | 11.77 mm | Standard Deviation 17.708 |
| RGN-259 | Corneal Sensitivity Using the Aesthesiometer (Cochet-Bonnet) | Corneal Sensitivity in Study Eye at 43 days | 12.87 mm | Standard Deviation 16.648 |
| Placebo | Corneal Sensitivity Using the Aesthesiometer (Cochet-Bonnet) | Corneal Sensitivity in Study Eye at 29 days | 14.38 mm | Standard Deviation 17.336 |
| Placebo | Corneal Sensitivity Using the Aesthesiometer (Cochet-Bonnet) | Corneal Sensitivity in Study Eye at 43 days | 18.33 mm | Standard Deviation 25.136 |
Other Pre-specified
Intraocular Pressure
Intraocular Pressure at 29, 43 days after first dosing
Time frame: 29, 43 days after first dosing
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RGN-259 | Intraocular Pressure | Intraocular Pressure in study eye at 29 days | 18.0 mmHg | Standard Deviation 6.6 |
| RGN-259 | Intraocular Pressure | Intraocular Pressure in study eye at 43 days | 16.8 mmHg | Standard Deviation 6.23 |
| Placebo | Intraocular Pressure | Intraocular Pressure in study eye at 29 days | 14.5 mmHg | Standard Deviation 4.41 |
| Placebo | Intraocular Pressure | Intraocular Pressure in study eye at 43 days | 12.5 mmHg | Standard Deviation 2.73 |
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.
Time frame: 29, 43 days after first dosing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RGN-259 | The Number of Participants With an Abnormal Findings by Dilated Fundoscopy at 29, 43 Days | Biomicroscopy in study eye at 29 days | 1 participants |
| RGN-259 | The Number of Participants With an Abnormal Findings by Dilated Fundoscopy at 29, 43 Days | Biomicroscopy in study eye at 43 days | 1 participants |
| Placebo | The Number of Participants With an Abnormal Findings by Dilated Fundoscopy at 29, 43 Days | Biomicroscopy in study eye at 29 days | 0 participants |
| Placebo | The Number of Participants With an Abnormal Findings by Dilated Fundoscopy at 29, 43 Days | Biomicroscopy in study eye at 43 days | 0 participants |
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.
Time frame: 8, 15, 22, 29, 36, 43 days after first dosing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RGN-259 | The Number of Participants With an Abnormal Findings by Slit-lamp Biomicroscopy at 8, 15, 22, 29, 36, 43 Days | Abnormal findings at 8 days | 6 participants |
| RGN-259 | The Number of Participants With an Abnormal Findings by Slit-lamp Biomicroscopy at 8, 15, 22, 29, 36, 43 Days | Abnormal findings at 15 days | 6 participants |
| RGN-259 | The Number of Participants With an Abnormal Findings by Slit-lamp Biomicroscopy at 8, 15, 22, 29, 36, 43 Days | Abnormal findings at 22 days | 6 participants |
| RGN-259 | The Number of Participants With an Abnormal Findings by Slit-lamp Biomicroscopy at 8, 15, 22, 29, 36, 43 Days | Abnormal findings at 29 days | 6 participants |
| RGN-259 | The Number of Participants With an Abnormal Findings by Slit-lamp Biomicroscopy at 8, 15, 22, 29, 36, 43 Days | Abnormal findings at 36 days | 7 participants |
| RGN-259 | The Number of Participants With an Abnormal Findings by Slit-lamp Biomicroscopy at 8, 15, 22, 29, 36, 43 Days | Abnormal findings at 43 days | 6 participants |
| Placebo | The Number of Participants With an Abnormal Findings by Slit-lamp Biomicroscopy at 8, 15, 22, 29, 36, 43 Days | Abnormal findings at 36 days | 5 participants |
| Placebo | The Number of Participants With an Abnormal Findings by Slit-lamp Biomicroscopy at 8, 15, 22, 29, 36, 43 Days | Abnormal findings at 8 days | 5 participants |
| Placebo | The Number of Participants With an Abnormal Findings by Slit-lamp Biomicroscopy at 8, 15, 22, 29, 36, 43 Days | Abnormal findings at 29 days | 5 participants |
| Placebo | The Number of Participants With an Abnormal Findings by Slit-lamp Biomicroscopy at 8, 15, 22, 29, 36, 43 Days | Abnormal findings at 15 days | 5 participants |
| Placebo | The Number of Participants With an Abnormal Findings by Slit-lamp Biomicroscopy at 8, 15, 22, 29, 36, 43 Days | Abnormal findings at 43 days | 5 participants |
| Placebo | The Number of Participants With an Abnormal Findings by Slit-lamp Biomicroscopy at 8, 15, 22, 29, 36, 43 Days | Abnormal findings at 22 days | 5 participants |