CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 37 enrolled
Drug / intervention
cenegermin-bkbjdrug
Likely dose
cenegermin-bkbj 20 mcgfrom 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/NCT04485546
NCT04485546Phase 4Completed

An 8-week, Multicenter, Open Label, Prospective Study With 24 Weeks of Follow-up to Evaluate Safety and Efficacy of OXERVATE® 0.002% (20 mcg/mL) Cenegermin-bkbj Ophthalmic Solution in Patients With Stage 1 Neurotrophic Keratitis (NK)

Dompé Farmaceutici S.p.A·interventional·Posted Jul 24, 2020·Updated Nov 17, 2025

In Brief

A Phase 4 clinical trial evaluating cenegermin-bkbj for Neurotrophic Keratitis. Completed, enrolled 37 participants across 5 sites.

Detailed Summary

This study is to evaluate the safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution in patients with Stage 1 neurotrophic keratitis (NK).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsDompé, US, Inc.

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedJul 24, 2020
Enrollment StartSep 9, 2020
Primary CompletionSep 30, 2021
Study CompletionMar 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.9 years ago

Interventions

cenegermin-bkbjdrug

OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution administered as one drop in the affected eye(s), 6 times a day at 2-hour intervals for 8 weeks, in patients with Stage 1 neurotrophic keratitis.