CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 174 enrolled
Drug / intervention
rhNGF 10 μg/ml +2 moredrug
Likely dose
rhNGF 10 μg/mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01756456
NCT01756456Phase 2Completed
CompareCT.gov

An 8-week Phase I/II, Multicenter, Randomized, Double-masked, Vehicle Controlled Parallel Group Study to Evaluate the Safety and Efficacy of Two Doses of Recombinant Human Nerve Growth Factor in Patients With Stage 2 and 3 of NK

Dompé Farmaceutici S.p.A·interventional·Posted Dec 27, 2012·Updated Apr 19, 2024

In Brief

A Phase 2 clinical trial evaluating rhNGF 10 μg/ml, rhNGF 20 μg/ml, and 1 other intervention for Neurotrophic Keratitis and 2 related conditions. Completed, enrolled 174 participants across 34 sites in 6 countries.

Detailed Summary

This study is aimed at assessing the safety and the efficacy of two dose regimens of recombinant human nerve growth factor (rhNGF) eye drops solution compared to vehicle for inducing a complete healing of stage 2 (persistent epithelial defect) and 3 (corneal ulcer) neurotrophic keratitis

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeurotrophic Keratitis, Keratitis, Corneal Ulcer
CountriesFrance, Germany, Italy, Poland, Spain, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 27, 2012
Enrollment StartJan 1, 2013
Primary CompletionApr 1, 2015
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.5 years ago

Interventions

rhNGF 10 μg/mldrug

rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF)

rhNGF 20 μg/mldrug

one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)

vehicleother

ophthalmic solution of the same composition as the test product without rhNGF