A 8 Weeks Study to Evaluate Efficacy & Safety of rhNGF vs Vehicle in Patients After Cataract and Refractive Surgery
Status:
Completed
Trial end date:
2017-09-04
Target enrollment:
Participant gender:
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).