At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 108 enrolled
Drug / intervention
Udonitrectag +1 moredrug
Likely dose
Not stated in 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.
Efficacy, Safety and Pharmacokinetics of 3 Doses of REC 0/0559 Eye Drops for the Treatment of Stage 2 (Moderate) and 3 (Severe) Neurotrophic Keratitis in Adult Patients
In Brief
A Phase 2 clinical trial evaluating Udonitrectag and Vehicle for Neurotrophic Keratitis. Completed, enrolled 108 participants across 41 sites in 7 countries.
Detailed Summary
A phase 2 study, aiming to evaluate the efficacy, safety and pharmacokinetics of REC 0/0559 in treatment of Neurotrophic Keratitis in Adult Patient in Europe and United States of America.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeurotrophic Keratitis
CountriesFrance, Germany, Hungary, Italy, Spain, United Kingdom, United States
CollaboratorsSyneos Health
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedFeb 2020
Enrollment StartOct 2020
Primary CompletionApr 2024
TodayJul 2026
First PostedFeb 19, 2020
Enrollment StartOct 13, 2020
Primary CompletionApr 29, 2024
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 6.4 years ago
Interventions
Udonitrectagdrug
Eye drop solution in single dose unit.
Vehicleother
Eye drop solution with no active substance in single dose unit.