CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
rhNGF 20µg/ml +1 moredrug
Likely dose
rhNGF 20µg/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/NCT02227147
NCT02227147Phase 2Completed
CompareCT.gov

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

Dompé Farmaceutici S.p.A·interventional·Posted Aug 27, 2014·Updated Dec 8, 2022

In Brief

A Phase 2 clinical trial evaluating rhNGF 20µg/ml and Placebo for Neurotrophic Keratitis. Completed, enrolled 48 participants across 12 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeurotrophic Keratitis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 27, 2014
Enrollment StartFeb 1, 2015
Primary CompletionJun 1, 2016
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.8 years ago

Interventions

rhNGF 20µg/mldrug

Placeboother

Formulation containing antioxidant