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

Phase 4

Completed

• Conditions: Neurotrophic Keratitis
• Interventions: Drug: cenegermin-bkbj

• Registration Number: NCT04485546
• Lead Sponsor: Dompé Farmaceutici S.p.A

Brief 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

Not available

Study Timeline

• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-23
• Study First Posted: 2020-07-24
• Study Start: 2020-09-09
• Primary Completion: 2021-09-30
• Study Completion: 2022-03-30
• Results First Submitted: 2023-05-22
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-22
• Results First Posted: 2023-06-23
• Last Update Submitted: 2023-06-23
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

1. Male or female aged ≥ 18 years.
2. Patients with Stage 1 NK defined by the Mackie criteria

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Exclusion Criteria

1. Evidence of an active ocular infection (bacterial, viral, protozoal) in either eye.
2. Have current or history of conditions that may confound the study data including but not limited to Ocular Cicatricial Pemphigoid (OCP), Graft Versus Host Disease (GVHD), neuromyelitis optica, uncontrolled dry eye, and Steven Johnson's syndrome.
3. History of severe systemic allergy or severe ocular allergy (including seasonal conjunctivitis expected during the subject's participation in the trial) or chronic conjunctivitis and/or keratitis other than dry eye disease.
4. Patients with severe vision loss with no potential for visual improvement in the study eye, in the opinion of the investigator, or if the subject is deemed legally blind.
5. Ocular surgery or elective ocular surgery expected during participation in the trial.
6. Patients with eyelid abnormality that may alter eyelid function including but not limited to Blepharospasm, Cerebrovascular accident, entropion, ectropion, floppy lid syndrome.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj	cenegermin-bkbj	-

Primary Outcome Measures

Name	Time	Method
Corneal Epithelial Healing	Week 8	Percentage of patients who experience corneal epithelial healing. Corneal epithelial healing was defined by the central reading center as the absence of persistent epithelial staining abnormalities related to disease.

Trial Locations

Locations (5)

Saint Louis; 🇺🇸 Saint Louis, Missouri, United States

San Diego; 🇺🇸 San Diego, California, United States

Edgewood; 🇺🇸 Edgewood, Kentucky, United States

Boston; 🇺🇸 Boston, Massachusetts, United States

Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States