NCT03035864

A 8 Weeks Study to Evaluate Efficacy & Safety of rhNGF vs Vehicle in Patients After Cataract and Refractive Surgery

A 8 Weeks, Phase II, Single-centre, Randomized, Double-masked, Vehicle-controlled, Parallel Group Study With 4 Weeks Follow-up to Evaluate Efficacy & Safety of rhNGF Eye Drops vs Vehicle in Patients After Cataract and Refractive Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Dompé Farmaceutici S.p.A · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The proposed phase II study is a single-centre, randomized, double masked, parallel arm, vehicle-controlled trial, designed to evaluate the preliminary efficacy and safety of rhNGF eye drops at 20 µg/ml concentration administered six times daily for 8 weeks in patients who underwent cataract and corneal refractive surgery, both known to damage the corneal sensory nerve plexus. After confirmation of inclusion and exclusion criteria all eligible patients will be randomized at 2:1 ratio to rhNGF or vehicle control treatment with 8 weeks of study treatments administration with 4 weeks Follow-up.

Conditions

• Ocular Discomfort

Interventions

Type	Name	Description
DRUG	rhNGF	Eye Drop 20 μg/mL
OTHER	Vehicle	Vehicle Eye Drop

Timeline

• Start date: 2017-01-12
• Primary completion: 2017-09-04
• Completion: 2017-09-04
• First posted: 2017-01-30
• Last updated: 2024-04-19
• Results posted: 2019-07-22

Locations

1 site across 1 country: Italy