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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-17

Study Completion Date

2020-03-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neurotrophic Keratopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RGN-259

It is a preservative-free, sterile eye drop solution containing Tβ4

Group Type EXPERIMENTAL

RGN-259

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

It is composed of the same excipients as RGN-259 but does not contain Tβ4

Interventions

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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.

Intervention Type DRUG

Placebo

It is composed of the same excipients as RGN-259 but does not contain Tβ4

Intervention Type DRUG

Other Intervention Names

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Tβ4 Vehicle Control

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No