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

NCT03035864 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-04-19

Study results available
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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).

Conditions

  • Ocular Discomfort

Interventions

DRUG

rhNGF

Eye Drop 20 μg/mL

OTHER

Vehicle

Vehicle Eye Drop

Sponsors & Collaborators

  • Dompé Farmaceutici S.p.A

    lead INDUSTRY

Principal Investigators

  • Leonardo Mastropasqua, MD · Univ. G. D'Annunzio- Clinica Oftalmologica Chieti

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-12
Primary Completion
2017-09-04
Completion
2017-09-04

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03035864 on ClinicalTrials.gov