Trial Outcomes & Findings for Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1 (NCT NCT02600429)
NCT ID: NCT02600429
Last Updated: 2023-08-30
Results Overview
Percentage of subjects achieving complete healing of the persistent epithelial defect as determined by corneal fluorescein staining at day 29 after first dosing.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
18 participants
Primary outcome timeframe
29 days after first dosing
Results posted on
2023-08-30
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1
Baseline characteristics by cohort
| Measure |
RGN-259
n=10 Participants
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.
|
Placebo
n=8 Participants
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
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 15.58 • n=5 Participants
|
72.5 years
STANDARD_DEVIATION 7.87 • n=7 Participants
|
67.6 years
STANDARD_DEVIATION 13.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 29 days after first dosingPercentage of subjects achieving complete healing of the persistent epithelial defect as determined by corneal fluorescein staining at day 29 after first dosing.
Outcome measures
| Measure |
RGN-259
n=10 Participants
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.
|
Placebo
n=8 Participants
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
|
|---|---|---|
|
Percentage of Subjects Achieving Complete Healing at Day 29.
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 8, 15, 22, 36, 43 days after first dosingPercentage 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.
Outcome measures
| Measure |
RGN-259
n=10 Participants
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.
|
Placebo
n=8 Participants
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
|
|---|---|---|
|
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
|
0 Participants
|
|
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
|
1 Participants
|
|
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
|
2 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
SECONDARY outcome
Timeframe: 8, 15, 22, 29, 36, 43 days after first dosingEpithelial Defect Measurement and Classification as stage 1, 2 or 3 using Mackie Classification at 8, 15, 22, 29, 36, 43 days after first dosing
Outcome measures
| Measure |
RGN-259
n=10 Participants
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.
|
Placebo
n=8 Participants
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
|
|---|---|---|
|
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
|
1 participants
|
|
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
|
2 participants
|
|
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
|
6 participants
|
|
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
|
0 participants
|
|
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
|
3 participants
|
|
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
|
5 participants
|
|
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
|
0 participants
|
|
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
|
3 participants
|
|
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
|
5 participants
|
|
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
|
0 participants
|
|
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
|
2 participants
|
|
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
|
6 participants
|
|
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
|
0 participants
|
|
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
|
1 participants
|
|
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
|
6 participants
|
|
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
|
1 participants
|
|
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
|
7 participants
|
|
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
|
0 participants
|
SECONDARY outcome
Timeframe: 29, 36, 43 days after first dosingTear Film Break-up Time at 29, 36, 43 days after first dosing
Outcome measures
| Measure |
RGN-259
n=10 Participants
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.
|
Placebo
n=8 Participants
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
|
|---|---|---|
|
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
|
4.018 Seconds
Standard Deviation 2.8758
|
|
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
|
3.658 Seconds
Standard Deviation 2.4115
|
|
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
|
3.889 Seconds
Standard Deviation 2.1701
|
SECONDARY outcome
Timeframe: 8, 15, 22, 29, 36, 43 days after first dosingOcular 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.)
Outcome measures
| Measure |
RGN-259
n=10 Participants
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.
|
Placebo
n=8 Participants
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
|
|---|---|---|
|
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
|
-0.3 score on a scale
Standard Deviation 1.04
|
|
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
|
-0.6 score on a scale
Standard Deviation 1.19
|
|
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
|
-0.4 score on a scale
Standard Deviation 0.92
|
|
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
|
-0.3 score on a scale
Standard Deviation 1.04
|
|
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
|
-0.1 score on a scale
Standard Deviation 0.99
|
|
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
|
-0.3 score on a scale
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: 8, 15, 22, 29, 36, 43 days after first dosingVisual 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.)
Outcome measures
| Measure |
RGN-259
n=10 Participants
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.
|
Placebo
n=8 Participants
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
|
|---|---|---|
|
Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days
Visual acuity(logMAR) at 8 days
|
1.451 logMAR
Standard Deviation 1.1873
|
1.090 logMAR
Standard Deviation 0.9697
|
|
Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days
Visual acuity(logMAR) at 15 days
|
1.370 logMAR
Standard Deviation 1.3068
|
1.017 logMAR
Standard Deviation 1.0184
|
|
Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days
Visual acuity(logMAR) at 22 days
|
1.287 logMAR
Standard Deviation 1.3616
|
1.020 logMAR
Standard Deviation 1.0097
|
|
Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days
Visual acuity(logMAR) at 29 days
|
1.323 logMAR
Standard Deviation 1.3283
|
1.003 logMAR
Standard Deviation 1.0315
|
|
Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days
Visual acuity(logMAR) at 36 days
|
1.280 logMAR
Standard Deviation 1.3542
|
0.990 logMAR
Standard Deviation 1.0315
|
|
Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days
Visual acuity(logMAR) at 43 days
|
1.424 logMAR
Standard Deviation 1.4556
|
0.997 logMAR
Standard Deviation 1.0292
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8, 15, 22, 29, 36, 43 days after first dosingThe 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.
Outcome measures
| Measure |
RGN-259
n=10 Participants
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.
|
Placebo
n=8 Participants
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
|
|---|---|---|
|
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
|
5 participants
|
|
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
|
5 participants
|
|
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
|
5 participants
|
|
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
|
5 participants
|
|
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
|
5 participants
|
|
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
|
5 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 29, 43 days after first dosingCorneal Sensitivity using the aesthesiometer (Cochet-Bonnet) at 29, 43 days after first dosing
Outcome measures
| Measure |
RGN-259
n=10 Participants
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.
|
Placebo
n=8 Participants
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
|
|---|---|---|
|
Corneal Sensitivity Using the Aesthesiometer (Cochet-Bonnet)
Corneal Sensitivity in Study Eye at 29 days
|
11.77 mm
Standard Deviation 17.708
|
14.38 mm
Standard Deviation 17.336
|
|
Corneal Sensitivity Using the Aesthesiometer (Cochet-Bonnet)
Corneal Sensitivity in Study Eye at 43 days
|
12.87 mm
Standard Deviation 16.648
|
18.33 mm
Standard Deviation 25.136
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 29, 43 days after first dosingThe 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.
Outcome measures
| Measure |
RGN-259
n=10 Participants
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.
|
Placebo
n=8 Participants
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
|
|---|---|---|
|
The Number of Participants With an Abnormal Findings by Dilated Fundoscopy at 29, 43 Days
Biomicroscopy in study eye at 29 days
|
1 participants
|
0 participants
|
|
The Number of Participants With an Abnormal Findings by Dilated Fundoscopy at 29, 43 Days
Biomicroscopy in study eye at 43 days
|
1 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 29, 43 days after first dosingIntraocular Pressure at 29, 43 days after first dosing
Outcome measures
| Measure |
RGN-259
n=10 Participants
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.
|
Placebo
n=8 Participants
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
|
|---|---|---|
|
Intraocular Pressure
Intraocular Pressure in study eye at 29 days
|
18.0 mmHg
Standard Deviation 6.60
|
14.5 mmHg
Standard Deviation 4.41
|
|
Intraocular Pressure
Intraocular Pressure in study eye at 43 days
|
16.8 mmHg
Standard Deviation 6.23
|
12.5 mmHg
Standard Deviation 2.73
|
Adverse Events
RGN-259
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RGN-259
n=10 participants at risk
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.
|
Placebo
n=8 participants at risk
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
|
|---|---|---|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/8 • 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.
|
Other adverse events
| Measure |
RGN-259
n=10 participants at risk
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.
|
Placebo
n=8 participants at risk
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
|
|---|---|---|
|
Eye disorders
Corneal epithelium defect
|
20.0%
2/10 • Number of events 2 • 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.
|
0.00%
0/8 • 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.
|
|
Eye disorders
Corneal opacity
|
10.0%
1/10 • Number of events 2 • 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.
|
0.00%
0/8 • 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.
|
|
Eye disorders
Keratic precipitates
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/8 • 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.
|
|
Eye disorders
Visual impairment
|
10.0%
1/10 • Number of events 1 • 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.
|
12.5%
1/8 • Number of events 1 • 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.
|
|
Eye disorders
Vitreous detachment
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/8 • 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.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/10 • 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.
|
12.5%
1/8 • Number of events 3 • 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.
|
|
General disorders
Inflammation
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/8 • 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.
|
|
Investigations
Blood glucose decreased
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/8 • 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.
|
|
Nervous system disorders
Unresponsive to stimuli
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/8 • 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.
|
|
Infections and infestations
Upper repiratory tract infection
|
0.00%
0/10 • 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.
|
12.5%
1/8 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place