Trials Sponsors Conditions Drugs Pricing

Conditions

Neurotrophic Keratopathy

Outcome Measures

Primary Outcomes (2)

Percentage of subjects achieving complete healing (defined as 0 mm lesion size) of the Persistent Epithelial Defect (PED) at Visit 5 (Day 29) determined by corneal fluorescein staining as measured by the Central Reading Center. The size of the lesion is based on the longest dimension (length or width) of the defect
Safety as determined by the frequency and severity of AEs as reported according to the NCI CTCAE version 5.0, changes from baseline in vital signs, changes in intraocular pressure (IOP), and results of the dilated fundoscopy and slit-lamp exams for both eyes

Secondary Outcomes (12)

Percentage of subjects achieving complete healing (defined as 0 mm lesion size) of the PED determined by corneal fluorescein staining as measured by the Central Reading Center at Visits 2, 3, 4, 6, and 7
Percentage of subjects achieving complete healing (defined as <0.5 mm lesion size) of the PED determined by corneal fluorescein staining as measured by the Investigator at Visits 2-7
Time to complete healing of the PED as measured by the Central Reading Center
Time to complete healing of the PED as measured by the Investigator
Percentage change from baseline of lesion size determined by corneal fluorescein staining as measured by the Central Reading Center at Visit 2-7 (measurements of greatest dimension of fluorescein staining)
+7 more secondary outcomes

Interventions

Timbetasin acetate ophthalmic solution 0.1%Type not reported

The placebo has the identical composition as the DP except it does not contain timbetasin acetate.Type not reported

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Be male or female of any race, at least 18 years of age at Visit 1
Have provided written informed consent
Be able and willing to follow instructions, including participation in all study assessments and visits

Sponsors & Collaborators

Regentree LLC
Industrylead

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Sites (25)

Azienda Ospedaliera Universitaria Gaetano Martino Messina

Messina, 98124, Italy

Anna Maria Roszkowska0902212277 aroszkowska@unime.it

Azienda Ospedaliera Di Padova

Padova, 35128, Italy

Andrea Leonardi0498212110 Andrea.leonardi@unipd.it

Azienda Ospedaliera S Giovanni Addolorata

Rome, 00184, Italy

Augusto Pocobelli0677052952

Central Study Contacts

Jihye Sung

000 jigel@regentreellc.com

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

February 13, 2023

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2022-502697-16-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 03:23:39 UTC

Documents

D1_ Protocol 2022-502697 16 00_Redacted

You may not qualify if:

Have any condition that, in the opinion of the Investigator, would interfere with the subject’s ability to complete the study, would interfere with the interpretation of safety or efficacy, or would present an undue risk to the subject. In cases of uncertainty, the Investigator should contact the medical monitor for clarification
Have any clinically significant slit-lamp findings in the study eye at Visit 1 that in the opinion of the Investigator may interfere with the study parameters; Examples include stromal keratitis, numerous punctate keratitis or pterygium, and thin cornea
Clinically significant active blepharitis, meibomian gland dysfunction (MGD), or lid margin inflammation, or active ocular allergy in study eye that requires treatment that in the opinion of the investigator may interfere with the study parameters;
Have a Unanesthetized Schirmer’s test score of ≤3 mm at Visit 1
Have a lid function abnormality (ex. Lagophthalmos) which, in the opinion of the Investigator, is the primary cause of the persistent epithelial defect
Have an ongoing ocular infection (bacterial, viral or fungal) or active inflammation (e.g., follicular conjunctivitis) in the study eye. Note that subjects with active stromal herpetic keratitis will also be excluded
Prior surgical procedure(s) for the treatment of NK (e.g. tarsorraphy, conjunctival flap, etc) within the three months before study enrollment with the exception of amniotic membrane transplantation. Subjects previously treated with amniotic membrane transplantation may only be enrolled after the membrane has disappeared within the area of the PED or at least four weeks after the date of the amniotic membrane transplantation procedure
Have any planned ocular surgical procedures or are likely to require ocular surgery for the study eye during the study
Have received Botox® injection to induce blepharoptosis in the study eye within 90 days prior to Visit 1
Have used contact lenses (for therapeutic or refractive correction) in the study eye within 14 days prior to Visit 1, or anticipate use of contact lenses during the study period. Note that consented subjects will be instructed to discontinue use of contact lenses for the study eye throughout the study
Have used OxervateTM in the study eye within the past 2 months
Anticipate use of serum tears in the study eye during the study period. Note that use of preservative free artificial tears for at least two weeks at the time of screening may continue throughout the study at the discretion of the Investigator
Have a presence or history of any ocular or systemic disorder or condition that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the Investigator to be incompatible with the study visit schedule or conduct (eg, progressive or degenerative corneal or retinal conditions, optic neuritis, systemic infection, neoplastic diseases, poorly controlled diabetes)
Have used drugs which affect lacrimation or function of the trigeminal nerve (e.g., neuroleptics, antipsychotics and anti-histamine drugs including oral pilocarpine and cevimeline, cholinergics including nasal varenicline, cytotoxic cancer therapy, neuroleptics, and antipsychotics) within 30 days of Visit 1 or anticipate use of these systemic medication throughout the course of the study
Have any autoimmune or chronic inflammatory disease that might have hindered the efficacy of the study treatment or its evaluation, could possibly have interfered with the interpretation of study results, or could have been judged by the Investigator to be incompatible with the study visit schedule or conduct (e.g., psoriasis, systemic lupus erythematosus, giant cell arteritis, polyarteritis nodosa, relapsing polychondritis, scleroderma, Behcet’s disease, reactive arthritis, inflammatory bowel disease, ankylosing spondylitis, Graves' disease)
+4 more criteria

SEER-3: A Phase 3, Multi-Center, Randomized, Parallel, Double Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of Neurotrophic Keratopathy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (12)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (25)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (12)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (25)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations