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NCT06244316 · ClinicalTrials.gov registry record · Phase 2
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.
A Phase 2 study of Dry Eye Disease, sponsored by Dompé Farmaceutici S.p.A.
- Completed
- Registry status
- Phase 2
- Development phase
- 317
- Enrollment target
- 14
- Study locations
NCT06244316: Completed Phase 2 study of Dry Eye Disease, sponsored by Dompé Farmaceutici S.p.A.
NCT06244316 is a Phase 2 study of Dry Eye Disease that has completed, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 317 participants, above the 245-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (29% higher). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06244316, a Phase 2 study of Dry Eye Disease, has completed, sponsored by Dompé Farmaceutici S.p.A.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 317 participants
- Enrollment target
- 14
- Study locations
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
Primary Outcome
SANDE questionnaire included 2 VAS-based questions that assessed: (i) DED symptom frequency (from 0 to 100) (ii) DED symptom severity (from 0 to 100) compiled by the participants. The global SANDE score (from 0 to 100, with 100 representing the most frequent and severe dry eye symptoms) was calculated by multiplying the frequency score by the severity score and obtaining the square root. For SANDE global Score, the lower the score, the better the outcome. Adjusted means are reported. Data here
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 |
What the finished NCT06244316 record still lists
NCT06244316 is an interventional study that assigns participants to a tested intervention. The registered 317 participants enrollment target is mid-sized for trials with a published cap, above the 245-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (29% higher).
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.
NCT06244316 lists 14 locations in 10 states (Other, Tennessee, Arizona).
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.
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).
Who is sponsoring clinical trial NCT06244316?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06244316's enrollment target sits among peer trials
317 9th of 33 higher than 25 of 33 other Dry Eye Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dry Eye Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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