NCT04485546

Study to Evaluate OXERVATE® in Patients With Stage 1 Neurotrophic Keratitis

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Dompé Farmaceutici S.p.A · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a 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)

Conditions

• Neurotrophic Keratitis

Interventions

Type	Name	Description
DRUG	cenegermin-bkbj	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.

Timeline

• Start date: 2020-09-09
• Primary completion: 2021-09-30
• Completion: 2022-03-30
• First posted: 2020-07-24
• Last updated: 2025-11-17
• Results posted: 2023-06-23

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study