MedTrace Logo

A Study to Evaluate Safety and Efficacy of rhNGF Eye Solution vs Vehicle in Patients With Moderate to Severe Dry Eye

NCT03982368 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2024-04-19

Study results available
· View outcomes & findings →

Summary

The objective of this study is to assess the efficacy and safety of rhNGF eye drops at 20 μg/ml concentration administered two or three times daily for 4 weeks in patients with moderate to severe dry eye.

Conditions

  • Dry Eye Syndrome

Interventions

DRUG

rhNGF 20 μg/ml

one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)

DRUG

rhNGF 20 μg/ml + vehicle

one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours). rhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.

OTHER

Vehicle

one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)

Sponsors & Collaborators

  • Dompé Farmaceutici S.p.A

    lead INDUSTRY

Principal Investigators

  • Flavio Mantelli, MD, PhD · Dompé Farmaceutici SpA

  • William Lipsky, MD · Advanced Laser Vision Surgical Institute (Study Site) Intouch Clinical Research Center (SMO)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-10
Primary Completion
2020-07-15
Completion
2020-07-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03982368 on ClinicalTrials.gov