Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1

Neurotrophic Keratopathy Clinical Trial

Official title:

Phase 3, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of RGN-259 Ophthalmic Solution for the Treatment of Neurotrophic Keratopathy: SEER-1

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02600429
• Other study ID #: RGN-NK-301
• Status: Terminated
• Phase: Phase 3
• Start date: September 17, 2015
• Est. completion date: March 9, 2020

Study information

• Verified date: July 2023
• Source: ReGenTree, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: March 9, 2020
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Neurotrophic Keratopathy

Intervention

Drug:
• RGN-259
A preservative-free, sterile eye drop solution containing Tß4 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 Tß4

Locations

Country	Name	City	State
United States	Vision Institute	Colorado Springs	Colorado
United States	Eye Center of Northern Colorado	Fort Collins	Colorado
United States	Midwest Cornea Associates, LLC	Indianapolis	Indiana
United States	Hull Eye Center	Lancaster	California
United States	Central Maine Eye Care	Lewiston	Maine
United States	Koffler Vision Group	Lexington	Kentucky
United States	Richard Eiferman, MD, PSC	Louisville	Kentucky
United States	The Eye Care Institute	Louisville	Kentucky
United States	Insight Vision Group	Parker	Colorado
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Medical Faculty Associates, Inc.	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
ReGenTree, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	8, 15, 22, 29, 36, 43 days after first dosing
Other	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
Other	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
Other	Intraocular Pressure	Intraocular Pressure at 29, 43 days after first dosing	29, 43 days after first dosing
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.	29 days after first dosing
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.	8, 15, 22, 36, 43 days after first dosing
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	8, 15, 22, 29, 36, 43 days after first dosing
Secondary	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
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.)	8, 15, 22, 29, 36, 43 days after first dosing
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.)	8, 15, 22, 29, 36, 43 days after first dosing