CompletedPhase 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.

United States317 participantsStarted 2024-01-22

Plain-language 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 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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Mean Change From Baseline to Week 8 in Symptoms of Dry Eye Assessed by Symptom Assessment in Dry Eye (SANDE) Global Score

Timeframe: Week 8 (V5)

Trial details

NCT IDNCT06244316

SponsorDompé Farmaceutici S.p.A

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-04

Results submitted2025-12-19

View on ClinicalTrials.gov More Dry Eye Disease trials