A 8 Weeks Study to Evaluate Efficacy & Safety of rhNGF vs Vehicle in Patients After Cataract and Refractive Surgery
Summary
The primary objective of this exploratory study is to assess preliminary efficacy and safety of rhNGF when administered as eye drops to patients after cataract and refractive surgery. The main criteria for evaluation were: * Change from baseline in SANDE scores for severity and frequency assessed at 8 weeks of treatment (primary efficacy endpoint) * Changes in Cornea vital staining with fluorescein (National Eye Institute \[NEI\] scales) assessed at 8 weeks of treatment (co-primary efficacy endpoint) * Changes in conjunctiva vital staining with fluorescein (NEI scales) (secondary efficacy endpoint); * Changes in Tear Film Break-Up Time (TFBUT)(secondary efficacy endpoint); * Changes in Cochet-Bonnet corneal aesthesiometry (secondary efficacy endpoint); * Changes in Nerve count and morphology at scanning laser in vivo corneal confocal microscopy (only patients who had Laser-Assisted In situ Keratomileusis \[LASIK\] surgery) (secondary efficacy endpoint); * Changes in SANDE scores (face values) for severity and frequency (secondary efficacy endpoint); * Incidence and frequency of treatment-emergent adverse events (TEAEs), assessed throughout the study (safety endpoint).
Timeline
- Start
- 2017-01-12
- Primary completion
- 2017-09-04
- Completion
- 2017-09-04
Outcome
Missed primary endpoint
registry analysis (superiority test); rhNGF 20 µg/ml vs Vehicle; p =0.974; difference in LS means -0.11 (95% CI -6.85 to 6.63); ANCOVA NCT03035864 ↗
registry analysis (superiority test); rhNGF 20 µg/ml vs Vehicle; p =0.399; Difference in least square means 2.88 (95% CI -3.85 to 9.61); ANCOVA NCT03035864 ↗
registry analysis (superiority test); rhNGF 20 µg/ml vs Vehicle; p =0.214; difference in least square means 0.04 (95% CI -0.02 to 0.10); ANCOVA NCT03035864 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rhNGF | Protein / enzyme biologic | 20 ug/ml | Topical |