Primary outcomeCount of participants· 29 days after first dosing
Percentage of Subjects Achieving Complete Healing at Day 29.
| Group | Value (Participants) |
|---|---|
| RGN-259 | 6 |
| Placebo | 1 |
Trial · Interventional
TerminatedPhase 3Results postedRegistry dataAssessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1
NCTNCT02600429 (opens ClinicalTrials.gov in a new tab)Other idRGN-NK-301
This trial was stopped early.
Reason given at the registry: Business decision
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 3
- Enrollment
- 18 participants (actual)
- Sponsor
- ReGenTree, LLC · Industry
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- 17 Sept 2015
- Primary completion
- 20 Nov 2019
- Completion
- 9 Mar 2020
- First posted
- 9 Nov 2015 (estimated)
- Last update posted
- 30 Aug 2023
- Conditions
- Neurotrophic Keratopathy
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2015201620172018201920202021
- Ph 3Terminated
Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1
NCT0260042917 Sept 2015 to 9 Mar 2020
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- RGN-259Drug
- PlaceboDrug
Arms2
Experimental
RGN-259
It is a preservative-free, sterile eye drop solution containing Tβ4
Placebo comparator
Placebo
It is composed of the same excipients as RGN-259 but does not contain Tβ4.
Primary outcomes1
Outcomes the sponsor listed as primary.
Percentage of Subjects Achieving Complete Healing at Day 29.
Time frame · 29 days after first dosing
Registry description
Percentage of subjects achieving complete healing of the persistent epithelial defect as determined by corneal fluorescein staining at day 29 after first dosing.
Secondary outcomes(5)
Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days
Time frame · 8, 15, 22, 36, 43 days after first dosing
Registry description
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.
Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification.
Time frame · 8, 15, 22, 29, 36, 43 days after first dosing
Registry description
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
Tear Film Break-up Time at 29, 36, 43 Days
Time frame · 29, 36, 43 days after first dosing
Registry description
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
Time frame · 8, 15, 22, 29, 36, 43 days after first dosing
Registry description
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
Time frame · 8, 15, 22, 29, 36, 43 days after first dosing
Registry description
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 results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeCount of participants· 8, 15, 22, 36, 43 days after first dosing
Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days
| Group | Value (Participants) |
|---|---|
| RGN-259 | 0 |
| Placebo | 0 |
Secondary outcomeNumber· 8, 15, 22, 29, 36, 43 days after first dosing
Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification.
| Group | Value (participants) |
|---|---|
| RGN-259 | 1 |
| Placebo | 2 |
Secondary outcomeMean· 29, 36, 43 days after first dosing
Tear Film Break-up Time at 29, 36, 43 Days
| Group | Value (Seconds) | Spread |
|---|---|---|
| RGN-259 | 4.444 | 3.3215 |
| Placebo | 4.018 | 2.8758 |
Secondary outcomeMean· 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
| Group | Value (score on a scale) | Spread |
|---|---|---|
| RGN-259 | -1.5 | 0.97 |
| Placebo | -0.6 | 1.19 |
Secondary outcomeMean· 8, 15, 22, 29, 36, 43 days after first dosing
Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days
| Group | Value (logMAR) | Spread |
|---|---|---|
| RGN-259 | 1.451 | 1.1873 |
| Placebo | 1.090 | 0.9697 |
Other pre specified outcomeNumber· 8, 15, 22, 29, 36, 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
| Group | Value (participants) |
|---|---|
| RGN-259 | 6 |
| Placebo | 5 |
Other pre specified outcomeMean· 29, 43 days after first dosing
Corneal Sensitivity Using the Aesthesiometer (Cochet-Bonnet)
| Group | Value (mm) | Spread |
|---|---|---|
| RGN-259 | 11.77 | 17.708 |
| Placebo | 14.38 | 17.336 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| RGN-259It 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 |
| PlaceboIt 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 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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;
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