18 and older, any sex, with Dry Eye. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Symptom Assessment in Dry Eye (SANDE) ScoresPrimary· week 8
Change from baseline with Last Observation Carried Forward (LOCF) imputation. LOCF is a method of imputing missing data in longitudinal studies and tests for difference in mean rates of change in controlled repeated measurements designs with dropouts.
The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Frequency
Group
Value
95% CI
rhNGF 20μg/mL
-38.8
± 28.97
Vehicle
-34.0
± 26.67
Severity
Group
Value
95% CI
rhNGF 20μg/mL
-32.2
± 31.04
Vehicle
-31.07
± 28.32
SANDE ScoresSecondary· Week 4, week 8, week 12
Change from baseline with Last Observation Carried Forward (LOCF) imputation. LOCF is a method of imputing missing data in longitudinal studies and tests for difference in mean rates of change in controlled repeated measurements designs with dropouts.
The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Changes from baseline on National Eye Institute (NEI) scale. The NEI/Industry Workshop guidelines were used for grading the scale of corneal and conjunctival damage. The cornea was divided into five sectors (central, superior, inferior, nasal and temporal), each of which was scored on a scale of 0-3, with a maximal total corneal staining score of 15.
Both nasally and temporally, the conjunctiva was divided into a superior paralimbal area, an inferior paralimbal area, and a peripheral area with a grading scale of 0-3 and with a maximal total score of 9 for the nasal and temporal conjunctiva (o
Changes from baseline on National Eye Institute (NEI) scale. The NEI/Industry Workshop guidelines were used for grading the scale of corneal and conjunctival damage. The cornea was divided into five sectors (central, superior, inferior, nasal and temporal), each of which was scored on a scale of 0-3, with a maximal total corneal staining score of 15.
Both nasally and temporally, the conjunctiva was divided into a superior paralimbal area, an inferior paralimbal area, and a peripheral area with a grading scale of 0-3 and with a maximal total score of 9 for the nasal and temporal conjunctiva (o
week 4
Group
Value
95% CI
rhNGF 20μg/mL
-4.7
± 3.94
Vehicle
-4.1
± 3.45
week 8
Group
Value
95% CI
rhNGF 20μg/mL
-6.7
± 4.16
Vehicle
-5.9
± 4.07
week 12
Group
Value
95% CI
rhNGF 20μg/mL
-7.2
± 4.23
Vehicle
-7.0
± 3.90
Change in Tear Film Break-up Time (TFBUT)Secondary· week 4, week 8, week 12
TFBUT was measured by determining the time to tear break-up. The TFBUT was performed after instillation of 5 μL of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient was instructed to blink several times to thoroughly mix the fluorescein with the tear film.
week 4
Group
Value
95% CI
rhNGF 20μg/mL
0.4
± 1.68
Vehicle
0.8
± 1.57
week 8
Group
Value
95% CI
rhNGF 20μg/mL
0.5
± 1.74
Vehicle
0.7
± 1.89
week 12
Group
Value
95% CI
rhNGF 20μg/mL
0.5
± 2.34
Vehicle
0.9
± 1.42
Change From Baseline in Wetting DistanceSecondary· week 8
The Schirmer test without anesthesia was performed to measure aqueous tear secretion prior to the instillation of any dilating or eye drops
Group
Value
95% CI
rhNGF 20μg/mL
2.4
± 11.41
Vehicle
-3.1
± 8.66
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination.
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
rhNGF 20μg/mL
Serious: 5/100 (5%)
Deaths: 0/100
Vehicle
Serious: 0/50 (0%)
Deaths: 0/50
Serious adverse events (5 terms)
Reaction
System
rhNGF 20μg/mL
Vehicle
Diverticulitis
Infections and infestations
—
—
Upper respiratory tract infection
Infections and infestations
—
—
Atrial fibrillation
Cardiac disorders
—
—
Paraesthesia
Nervous system disorders
—
—
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
—
—
Other adverse events (148 terms — click to expand)
The primary objective of this study was to assess the efficacy and safety of rhNGF when administered as eye drops to patients with dry eye
The secondary objectives of this study were:
* To assess change from baseline in Symptom Assessment In Dry Eye (SANDE) scores (without imputation), corneal and conjunctival staining according to National Eye Institute (NEI) scale, and in Tear Film Break-up Time (TFBUT) and Schirmer test I, following 4 and 8 weeks of treatment.
* To assess change in levels of inflammatory biomarker matrix metallopeptidase 9 (MMP-9) in tears following 8 weeks of treatment.
* To assess the incidence and frequency of treatment-emergent adverse events (TEAEs) following 8 weeks of treatment.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03844243 — Exercise-induced Ischemia and the Influence of Pain Modulation in a Nerve Growth Factor (NGF) Model
· EARLY_PHASE1
· unknown
NCT03470038 — Interaction Between NGF and Acute Exercise-induced Ischemia
· EARLY_PHASE1
· completed
NCT03217942 — Spread of Muscle Hyperalgesia and Pain in a Low Dose NGF-induced Pain Model
· EARLY_PHASE1
· completed
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Other Dompé Farmaceutici S.p.A trials
Trials by the same sponsor.
NCT06411132 — Study to Evaluate Corneal Neurosensory Abnormalities in Patients With Sjögren's Dry Eye
· terminated
NCT06411145 — Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis
· Phase 4
· withdrawn
NCT06244316 — A Safety and Efficacy Study of 2 Dosing Regimens of Recombinant Human Nerve Growth Factor (rhNGF) Eye Drop Solution Comp
· Phase 2
· completed
NCT05552261 — DEFENDO Long Term Follow-up Study in Stage 1 NK Patients
· completed
NCT05496868 — Add-on Reparixin in Adult Patients With ARDS
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dompé Farmaceutici S.p.A
Last refreshed: 8 February 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03019627.