Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Recombinant Human Nerve Growth Factor Eye Drop Solution in Participants With Persistent Corneal Epithelial Defect (PCED)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523443-35-00

Enrollment

Registered

2026-05-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Corneal Epithelial Defect (PCED)

Brief summary

Achieving complete epithelial healing at week 4 and maintained at week 8.

Detailed description

Percentage change from baseline in maximum diameter of PCED at week 4, Percentage change from baseline in maximum diameter of PCED at week 8, Achieving complete epithelial healing at week 8 and maintained at week 10, Linear change from baseline in maximum diameter (in mm) of the PCED at week 4

Interventions

DRUGVehicle for cenegermin drug product

DRUGCOLIROFTA ANESTÉSICO DOBLE 1 MG/ML + 4 MG/ML COLIRIO EN SOLUCIÓN

DRUGOXERVATE 20 micrograms/ml eye drops

DRUGsolution

DRUGTROPICAMIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Achieving complete epithelial healing at week 4 and maintained at week 8.	—

Secondary

Measure	Time frame
Percentage change from baseline in maximum diameter of PCED at week 4, Percentage change from baseline in maximum diameter of PCED at week 8, Achieving complete epithelial healing at week 8 and maintained at week 10, Linear change from baseline in maximum diameter (in mm) of the PCED at week 4	—

Outcome results

None listed

Source: EU CTIS · Data processed: May 7, 2026