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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.
NCT06244316 · View on ClinicalTrials.gov ↗
Study Summary
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
Conditions Studied
Interventions
- DRUG rhNGF 5 μg/mL
- DRUG rhNGF 10 μg/mL
- DRUG Vehicle (Placebo solution)
Study Locations (14)
Other
- Azienda Ospedaliera Universitaria Policlinico G Martino — Messina
- Ospedale S. Giuseppe Multimedica — Milan
- Fondazione Policlinico Universitario Campus Bio-Medico di Roma — Roma
- Azienda Ospedaliero Universitario Policlinicol Umberto I — Roma
Tennessee
- Total Eye Care PA — Memphis
- Toyos Clinic — Nashville
Arizona
- Arizona Eye Center — Chandler
California
- East West Eye Institute — Torrance
Colorado
- Vision Institute - Fontanero St — Colorado Springs
Florida
- Sibia Eye Institute — Boynton Beach
Georgia
- Eye Consultants of Atlanta — Atlanta
Massachusetts
- New England Eye Center - Boston — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 317 participants |
| Start Date | 2024-01-22 |
| Est. Completion | 2024-12-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06244316
The ClinicalTrials.gov registry entry for NCT06244316 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 317 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dompé Farmaceutici S.p.A, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Dry Eye Disease appearing as the primary indexed condition, and to 3 interventions — of which rhNGF 5 μg/mL is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06244316 reports 14 study locations spanning 10 distinct geographic areas — top geographies include Other, Tennessee, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06244316 about?
NCT06244316 is a clinical study titled "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.". 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 participan...
What is the current status of trial NCT06244316?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 317 participants. The study started on 2024-01-22. Estimated completion is 2024-12-04.
What conditions does trial NCT06244316 study?
This clinical trial studies the following conditions: Dry Eye Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06244316?
The interventions under investigation include: rhNGF 5 μg/mL (DRUG), rhNGF 10 μg/mL (DRUG), Vehicle (Placebo solution) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06244316?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06244316 being conducted?
This trial has 14 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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