Status:
COMPLETED
Study to Evaluate OXERVATE® in Patients With Stage 1 Neurotrophic Keratitis
Lead Sponsor:
Dompé Farmaceutici S.p.A
Collaborating Sponsors:
Dompé US
Conditions:
Neurotrophic Keratitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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
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 ...
Eligibility Criteria
Inclusion
- Male or female aged ≥ 18 years.
- Patients with Stage 1 NK defined by the Mackie criteria
Exclusion
- Evidence of an active ocular infection (bacterial, viral, protozoal) in either eye.
- 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.
- 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.
- 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.
- Ocular surgery or elective ocular surgery expected during participation in the trial.
- Patients with eyelid abnormality that may alter eyelid function including but not limited to Blepharospasm, Cerebrovascular accident, entropion, ectropion, floppy lid syndrome.
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04485546
Start Date
September 9 2020
End Date
March 30 2022
Last Update
November 17 2025
Active Locations (5)
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1
San Diego
San Diego, California, United States, 92122
2
Edgewood
Edgewood, Kentucky, United States, 41017
3
Boston
Boston, Massachusetts, United States, 02111
4
Saint Louis
St Louis, Missouri, United States, 63131