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Completed Phase 2 Interventional Results available

Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 NK

ClinicalTrials.gov ID: NCT02227147

Public ClinicalTrials.gov record NCT02227147. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 30, 2026, 11:35 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An 8-week Phase II, Multicenter, Randomized, Double-masked, Vehicle Controlled Parallel Group Study With a 24 or 32 Week Follow-up to Evaluate the Efficacy of rhNGF 20 µg/ml vs Vehicle in Patients With Stage 2 and 3 Neurotrophic Keratitis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary objective of this study is to evaluate the efficacy of 20 µg/ml 6 times a day of rhNGF eye drops solution (formulation containing anti-oxidant) compared to vehicle (formulation containing anti-oxidant) given 6 times a day. The evaluation of efficacy is intended as: * complete healing of stage 2 (persistent epithelial defect) and 3 (corneal ulcer) neurotrophic keratitis (NK) as measured by the central reading center using corneal fluorescein staining, * assessing the duration of complete healing, * improvement in visual acuity and improvement in corneal sensitivity.

Study identification

NCT ID
NCT02227147
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Dompé Farmaceutici S.p.A
Industry
Enrollment
48 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2015 (Type not available)
Primary completion
Jun 2016 (Actual)
Completion
Sep 2016 (Actual)
Last update posted
Dec 8, 2022

2015 – 2016

United States locations

U.S. sites
12
U.S. states
7
U.S. cities
11
Facility City State ZIP Site status
Loma Linda University Ophthalmology Loma Linda California 92354 —
Jules Stein Eye Institute Los Angeles California 90095 —
Shiley Eye Center University of California San Diego California 92093 —
Bascom Palmer Eye Institute University of Miami Miami Florida 33324 —
Tufts Medical Center Boston Massachusetts 02111 —
Massachusetts Eye & Ear Infirmary Boston Massachusetts 02114 —
Massachusetts Eye Research and Surgery Institution Cambridge Massachusetts 02451 —
Mayo Clinic Rochester Minnesota 55905 —
New York Eye and Ear Infirmary New York New York 10003 —
Penn Eye Care Scheie Eye Institute Philadelphia Pennsylvania 19104 —
UPMC eye center, department of ophthalmology, University of Pittsburgh Pittsburgh Pennsylvania 15213 —
Baylor College of Medicine Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02227147, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 8, 2022 · Synced Oct 30, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02227147 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →