An 8-week Study to Evaluate Safety and Efficacy of NGF Eye Drops Solution Versus Vehicle in Patients With Dry Eye
Summary
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.
Timeline
- Start
- 2017-01-20
- Primary completion
- 2017-08-31
- Completion
- 2017-08-31
Outcome
Missed primary endpoint
registry analysis (superiority test); rhNGF 20μg/mL vs Vehicle; p =0.428; difference in least square means -3.83 (95% CI -13.34 to 5.68); ANCOVA NCT03019627 ↗
registry analysis (superiority test); rhNGF 20μg/mL vs Vehicle; p =0.974; difference in least square means 0.16 (95% CI -9.45 to 9.76); ANCOVA NCT03019627 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rhNGF | Protein / enzyme biologic | 20 ug/ml | Other |