A Safety and Efficacy Study of 2 Dosing Regimens of Recombinant Human Nerve Growth Factor (rhNGF) Eye Drop Solution Compared With Vehicle in Patients With Dry Eye Disease.

Completed · Phase 2 · Has a placebo group

Conditions studied: Dry Eye Disease

In brief

Primary objective • To evaluate the efficacy of 5 μg/mL and 10 μg/mL concentrations of the new formulation of rhNGF ophthalmic solution versus vehicle, in order to demonstrate superiority of at least 1 of the concentrations over vehicle in the improvement of ocular symptoms of dry eye in participants with dry eye disease (DED) Key secondary objectives * To evaluate the efficacy of the new formulation of rhNGF ophthalmic solution in increasing the number of participants with improved reflex tear production as compared to vehicle at week 4 * To evaluate the efficacy of the new formulation of rhNGF ophthalmic solution in improving reflex tear production as compared to vehicle at week 4 * To evaluate the efficacy of the new formulation of rhNGF ophthalmic solution in improving ocular surface integrity (corneal epitheliopathy) as compared to vehicle at week 4 Secondary objectives * To evaluate the efficacy of the new formulation of rhNGF ophthalmic solution in improving reflex tear production as compared to vehicle at week 8 * To evaluate the efficacy of the new formulation of rhNGF ophthalmic solution in improving tear film stability as compared to vehicle at weeks 4 and 8 * To evaluate the efficacy of the new formulation of rhNGF ophthalmic solution in improving ocular surface integrity (corneal and conjunctival epitheliopathy) as compared to vehicle at weeks 4 and 8 * To evaluate the efficacy of the new formulation of rhNGF ophthalmic solution in improving the severity and frequency of dry eye symptoms as compared to vehicle at weeks 4 and 8 * To evaluate the efficacy of the new formulation of rhNGF ophthalmic solution in improving dry eye symptoms as compared to vehicle at week 4 * To evaluate the efficacy of the new formulation of rhNGF ophthalmic solution in improving associated symptoms in DED as compared to vehicle at weeks 4 and 8 * To evaluate the efficacy of the new formulation of rhNGF ophthalmic solution in improving the quality of life in participants with DED as compared to vehicle at weeks 4 and 8 * To evaluate the efficacy of the new formulation of rhNGF ophthalmic solution in improving best corrected visual acuity in DED as compared to vehicle at weeks 4 and 8 Safety objectives * To evaluate safety/tolerability of the new formulation of rhNGF ophthalmic solution * To evaluate safety of the new formulation of rhNGF ophthalmic solution * To evaluate tolerability of the new formulation of rhNGF ophthalmic solution

Key facts

Study ID: NCT06244316
Run by: Dompé Farmaceutici S.p.A
People needed: 317
Starts: 2024-01-22
Expected to finish: 2024-12-04
Last updated by the study team: 2026-02-13

Who can join

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

You may qualify if…

Male or female aged ≥18 years of any race/ethnicity and eye color.
A diagnosis of dry eye disease at least 6 months before enrollment (current use or recommended use of artificial tears for the treatment of dry eye).
Moderate-to-severe dry eye characterized by the following clinical features:
Symptoms Assessment in Dry Eye (SANDE) questionnaire global score ≥50, and
Schirmer-I test without anesthesia >2 mm and <10 mm/5 minutes, and
Total corneal fluorescein staining grade ≥3 (NEI scale) and/or total conjunctival lissamine green staining score ≥3 assessed by the NEI grading system, and
Fluorescein tear film break-up time (fTBUT) < 10 seconds The same eye must have fulfilled all the above criteria.
Best corrected distance visual acuity (BCDVA) score on ETDRS chart of ≥0.1 decimal units (≤1.0 logarithm of the minimum angle of resolution [logMAR]) in each eye at the time of study enrollment
Negative pregnancy test in females of childbearing potential.
Only participants who satisfy all informed consent requirements were included in the study; the participant and/or his/her legal representative must have read, signed, and dated the informed consent document before any study-related procedures were performed; the informed consent form signed by participants and/or legal representatives must have been approved by the Institutional Review Board (IRB) for the current study.
Have the ability and willingness to comply with study procedures.

You may not qualify if…

Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments.
Evidence of an active ocular infection in either eye.
Presence of any other ocular disorder or condition requiring topical ocular medication during the entire duration of the study.
Possibility of the need for ocular surgery at the time of inclusion in the study or anticipated ocular surgery expected during the participation in the study
History of severe systemic allergy or severe ocular allergy [including seasonal conjunctivitis, AKC (Atopic KeratoConjunctivitis), VKC (Vernal KeratoConjunctivitis)] or chronic conjunctivitis and/or keratitis other than dry eye.
Ocular scarring due to irradiation, alkali burns, Stevens-Johnson syndrome and ocular cicatricial pemphigoid.
Destruction of conjunctival goblet cells such as in Vitamin A deficiency.
Severe blepharitis or obvious inflammation of the lid margin.
Intraocular inflammation defined as Tyndall score >0.
Medical history of tumor malignancy in the previous 3 years
Systemic disease not stabilized within 1 month before the screening visit (e.g., diabetes with glycemia out of range, thyroid malfunction) or judged by the investigator to be incompatible with the study (e.g., current systemic infections) or with a condition incompatible with the frequent assessment required by the study.
History of a serious adverse reaction or significant hypersensitivity to any drug or chemically related compounds or had a clinically significant allergy to drugs, foods, topical anesthetic eye drop or other local anesthetics or other materials, including ocular vital dyes, tropicamide eye drops, commercial artificial tears.
Known or suspected allergy to sesame and other seeds, tree nuts, and/or peanuts, and/or any other component of the new rhNGF formulation.
Fertile patients (i.e., not surgically sterilized, or postmenopausal women for at least 1 year) are excluded from participation in the study if they do not practice abstinence from heterosexual intercourse as per usual and customary lifestyle, or are unwilling to use an acceptable form of contraception such as condom with spermicidal cream or jelly for males, or for females if they meet any one of the following conditions:
Currently pregnant (positive urine pregnancy test at screening or baseline visits) or planning to become pregnant during the duration of the treatment phase of the clinical trial.
Participant is breastfeeding.
Unwilling to use birth control measures such as mechanical barrier methods (spermicide in conjunction with a barrier such as a condom or diaphragm or intrauterine device) during the entire course of and 30 days after the study treatment period, or,
Unwilling to continue to use highly effective birth control measures such as hormonal contraceptives (oral, implanted, transdermal, or injected) during the entire course of and 30 days after the study treatment period.
Any concurrent medical condition that, in the judgment of the principal investigator, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the participant's well-being.
Contact lenses or punctum plug use in either eye during the washout, treatment, and follow-up phases of the study (previous use is not an exclusion criteria but must be removed and discontinued at the Screening visit).
Medical history of drug addiction or alcohol abuse (>1 drink /day for women and >2 drinks /day for men following USDA dietary Guidelines 2020-2025).
Any prior ocular surgery, including but not limited to amniotic membrane transplant, refractive [PTK (Excimer Laser Phototherapeutic Keratectomy) / LASIK (Laser-Assisted In Situ Keratomileusis) / Epi-LASIK (Epithelial Laser In Situ Keratomileusis) / LASEK (Laser-Assisted Subepithelial Keratectomy) / SMILE (Small Incision Lenticule Extraction)], palpebral, cataract surgery, trabeculectomy, vitrectomy and Pan-Retinal Photocoagulation (PRP) within 90 days before the screening visit.
Participation in a clinical trial with a new active substance, including medical devices, during the previous 60 days.
Participation in another clinical trial study at the same time as the present study.

Where it is running

Arizona Eye Center — Chandler, Arizona, United States
East West Eye Institute — Torrance, California, United States
Vision Institute - Fontanero St — Colorado Springs, Colorado, United States
Sibia Eye Institute — Boynton Beach, Florida, United States
Eye Consultants of Atlanta — Atlanta, Georgia, United States
New England Eye Center - Boston — Boston, Massachusetts, United States
Eye Associates of North Jersey — Dover, New Jersey, United States
The Scheie Eye Institute — Philadelphia, Pennsylvania, United States
Total Eye Care PA — Memphis, Tennessee, United States
Toyos Clinic — Nashville, Tennessee, United States
Azienda Ospedaliera Universitaria Policlinico G Martino — Messina, Italy
Ospedale S. Giuseppe Multimedica — Milan, Italy
Fondazione Policlinico Universitario Campus Bio-Medico di Roma — Roma, Italy
Azienda Ospedaliero Universitario Policlinicol Umberto I — Roma, Italy

Full record on ClinicalTrials.gov

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