Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Neurotrophic Keratopathy

In brief

The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)

Key facts

Study ID: NCT05555589
Run by: ReGenTree, LLC
People needed: 70
Starts: 2023-04-11
Expected to finish: 2026-05-30
Last updated by the study team: 2025-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Be male or female of any race, at least 18 years of age;
Have provided written informed consent;
Be able and willing to follow instructions, including participation in all study assessments and visits;
At the time of Visit 1, have documentation or observation of a Persistent Epithelial Defect (PED) in one or both eyes, defined as a corneal epithelial defect that has not resolved after 1 week of conventional treatment using non-preserved ocular lubricants, non-preserved topical ophthalmic antibiotics, oral doxycycline, patching, amniotic membrane, serum tears, and/or therapeutic contact lenses;
Have stage 2 or 3 neurotrophic keratopathy (Mackie Classification) in at least one eye of which the longest dimension (length or width) of the defect measures a minimum length of 1 mm (study eye) and which is confirmed by the Investigator not to be simply superficial punctate keratitis, at Visit 1;
Have evidence of decreased corneal sensitivity ≤40 mm using the Cochet-Bonnet aesthesiometer at Visit 1;
Have BCVA score ≤75 letter counts in the study eye based on the ETDRS protocol;
Have at least one eye (the same eye) satisfy all criteria for d, e, f, g above;
Female subjects of child-bearing potential must be non-lactating and using and agree to continue using an acceptable method of contraception for at least 4 weeks prior to the first dose of study product and until 12 weeks after last dose, and have a negative urine pregnancy test during screening;
Male subjects must agree to use an adequate method of contraception.

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.
Have any clinically significant slit-lamp findings in the study eye that in the opinion of the Investigator may interfere with the study parameters;
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.
History of any ocular surgery (including laser or refractive surgical procedures) within the three months before study enrollment.
Prior surgical procedure(s) for the treatment of NK (e.g., tarsorrhaphy, conjunctival flap, etc.) within the three months before study enrollment with the exception of amniotic membrane transplantation.
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.
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.
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;
Have used drugs which affect lacrimation or function of the trigeminal nerve 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;
Be on topical (Ocular/Nasal) immunosuppressive therapy within 30 days prior to screening or is likely to require this during the course of the study;
Have a known allergy and/or sensitivity to the study product or its components;
History of drug, medication or alcohol abuse or addiction;
Have participated in an investigational drug study within 30 days prior to screening;
Have fever, inflammation, or systemic signs of illness suggestive of systemic or invasive infection, including COVID-19 or a positive test for COVID-19, within 2 weeks prior to first dose of study drug.

Where it is running

Harvard Eye Associates — Laguna Hills, California, United States (enrolling)
Loma Linda University Eye Institute — Loma Linda, California, United States (enrolling)
Gabinet Okulistyczny Prof Edward Wylegala — Katowice, Silesian Voivodeship, Poland (enrolling)
IMO Barcelona, Grupo Miranza — Barcelona, Barcelona, Spain (enrolling)
Hospital La Arruzafa — Córdoba, Córdoba, Spain (enrolling)
Instituto Oftalmológico Fernández-Vega — Oviedo, Principality of Asturias, Spain (enrolling)
Aiken Prevención & Cirugía Ocular — Valencia, Valencia, Spain (enrolling)
Advance Vision Research Institute — Longmont, Colorado, United States (enrolling)
Connecticut Eye Consultants, P.C. Danbury Eye Physicians & Surgeons — Danbury, Connecticut, United States (enrolling)
Nature Coast Clinical Research — Crystal River, Florida, United States (enrolling)
University of Miami - Bascom Palmer Eye Institute, Miami — Miami, Florida, United States (enrolling)
University of South Florida, Ophthalmolgoy — Tampa, Florida, United States (enrolling)
Thomas Eye Group, P.C. — Sandy Springs, Georgia, United States (enrolling)
Northwestern — Chicago, Illinois, United States (enrolling)
Midwest Cornea Associates, LLC. — Carmel, Indiana, United States (enrolling)
Midwest Vision Research Foundation — Chesterfield, Missouri, United States (enrolling)
Washington University Eye Center — St Louis, Missouri, United States (enrolling)
Metropolitan Eye Research and Surgery Institute — Palisades Park, New Jersey, United States (enrolling)
Montefiore Medical Center — The Bronx, New York, United States (enrolling)
Duke Eye Center — Durham, North Carolina, United States (enrolling)
University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
Cleveland Clinic, Cole Eye Institute — Cleveland, Ohio, United States (enrolling)
Cataract & Laser Institute of Southern Oregon — Medford, Oregon, United States (enrolling)
OHSU Casey Eye Institute — Portland, Oregon, United States (enrolling)
UPMC Eye Center — Pittsburgh, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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