Clinical trials: Neurotrophic Keratitis
Neurotrophic Keratitis
Efficacy and Safety of Plasma Rich in Growth Factors (PRGF-Endoret) Eye-drops in the Treatment of Neurotrophic Keratitis
Neurotrophic keratitis (NK) is a rare degenerative corneal disease caused by altered innervation of the trigeminal nerve that leads to rupture of the corneal epithelium, the regeneration deterioration and development of corneal…
- Trial name
- NCT02707120
- Testing
- PRGF-Endoret, Artificial tears eye-drops
- Where
- 4 sites in Spain
- Sponsor
- Biotechnology Institute IMASD
Neurotrophic Keratitis
REC 0/0559 Eye Drops for Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients
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.
- Trial name
- NCT04276558
- Testing
- Udonitrectag, Vehicle
- Where
- 41 sites in United States, France and 5 more
- Volunteers
- 108 people
- Sponsor
- RECORDATI GROUP
Neurotrophic Keratitis
A Study of STSP-0902 Ophthalmic Solution in Healthy Subjects
This trial is a Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic (PK) characteristics of STSP-0902 ophthalmic solution in healthy subjects following single and multiple administrations.
- Trial name
- NCT06597422
- Testing
- STSP-0902 ophthalmic solution
- Where
- China
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
Neurotrophic Keratitis
Study to Evaluate OXERVATE® in Patients With Stage 1 Neurotrophic Keratitis
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).
- Trial name
- DEFENDO (NCT04485546)
- Testing
- cenegermin-bkbj
- Where
- 5 sites in United States
- Volunteers
- 37 people
- Sponsor
- Dompé Farmaceutici S.p.A
Corneal Epithelial Defect
To Evaluate the Efficacy and Safety of ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defects Caused by Neurotrophic Keratitis
An investigator-initiated single-center, randomized, double-blind, placebo-controlled clinical study .The main purpose is to evaluate the effectiveness of ZKY001 eye drops in treating corneal epithelial defects caused by…
- Trial name
- NCT07120308
- Testing
- ZKY001 eye drops
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Persistent Corneal Epithelial Defect
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
This is a phase 3, randomized, multicenter, double-masked, parallel group, vehicle-controlled prospective clinical trial to evaluate the safety and efficacy of cenegermin in inducing complete epithelial healing in participants…
- Trial name
- NCT07519902
- Testing
- Cenegermin, Vehicle
- Where
- 77 sites in United States, Argentina and 12 more
- Volunteers
- 150 people
- Sponsor
- Dompé Farmaceutici S.p.A
Neurotrophic Keratitis
A Study Comparing KB801 Verse Placebo in Patients With Stage 2 or 3 Neurotrophic Keratitis
The Sponsor is developing KB801, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human nerve growth factor (NGF) to the corneas of people…
- Trial name
- EMERALD-1 (NCT06999733)
- Testing
- KB801
- Where
- 9 sites in United States
- Volunteers
- 60 people
- Sponsor
- Krystal Biotech, Inc.
Neurotrophic Keratopathy
Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1
The objective of this study is to assess the safety and efficacy of RGN-259 Ophthalmic Solution compared to placebo for the treatment of NK.
- Trial name
- NCT02600429
- Testing
- RGN-259
- Where
- 11 sites in United States
- Volunteers
- 18 people
- Sponsor
- ReGenTree, LLC
Neurotrophic Keratopathy
Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2
The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)
- Trial name
- NCT05555589
- Testing
- RGN-259
- Where
- 36 sites in United States, Italy and 2 more
- Volunteers
- 70 people
- Sponsor
- ReGenTree, LLC
Neurotrophic Keratitis
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects
This study will enroll subjects with stage 2 or 3 neurotrophic keratitis. Subjects will be randomized in a 1:1 ratio to the CSB-001 investigational treatment arm or vehicle control arm.
- Trial name
- NCT04909450
- Testing
- CSB-001 Ophthalmic Solution 0.1%, Vehicle Control
- Where
- 48 sites in United States, Canada
- Volunteers
- 131 people
- Sponsor
- Claris Biotherapeutics, Inc.
Neurotrophic Keratitis, Keratitis
Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis.
This study is aimed at assessing the safety and the efficacy of two dose regimens of recombinant human nerve growth factor (rhNGF) eye drops solution compared to vehicle for inducing a complete healing of stage 2 (persistent…
- Conditions
- Neurotrophic Keratitis, Keratitis, Corneal Ulcer
- Trial name
- REPARO (NCT01756456)
- Testing
- rhNGF 10 μg/ml, rhNGF 20 μg/ml, vehicle
- Where
- 34 sites in France, Germany and 4 more
- Volunteers
- 174 people
- Sponsor
- Dompé Farmaceutici S.p.A
Neurotrophic Keratitis
A Phase II Study of STSP-0902 Ophthalmic Solution in Patients With Neurotrophic Keratitis
This is a Phase II, double-blind, placebo-controlled study to evaluate the safety and efficacy of STSP-0902 ophthalmic solution in patients with neurotrophic keratitis (NK).
- Trial name
- NCT06975748
- Testing
- STSP-0902 ophthalmic solution
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
Neurotrophic Keratitis
Assessment of the Initial Efficacy and Safety of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis
The objective of this study is to obtain initial efficacy of BRM424 in patients with Stage 2 and Stage 3 NK and evaluate safety and tolerability.
- Trial name
- NCT05927428
- Testing
- BRM424 Ophthalmic Solution - Dose1, BRM424 Ophthalmic Solution - Dose2
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- BRIM Biotechnology Inc.
Neurotrophic Keratitis
DEFENDO Long Term Follow-up Study in Stage 1 NK Patients
Primary Objective To evaluate the long-term safety and efficacy (healing) of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution in Stage 1 neurotrophic keratitis (NK) patients who enrolled in the DEFENDO study.
- Trial name
- NCT05552261
- Testing
- Cenegemin in the DEFENDO Study
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Dompé Farmaceutici S.p.A
Neurotrophic Keratitis
A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep in Subjects With Neurotrophic Keratitis
Objective: To evaluate the safety of Lacripep 4 μM Ophthalmic Solution and its effect on the ocular surface, visual function, corneal sensitivity, and quality of life of subjects with Stage 1 NK.
- Trial name
- NCT07568730
- Testing
- Lacripep, Vehicle Ophthalmic Solution
- Where
- 6 sites in United States
- Volunteers
- 54 people
- Sponsor
- TearSolutions, Inc.
Keratitis, Corneal Ulcer
Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer
The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.
- Trial name
- NCT01794312
- Testing
- T4020, Vehicle
- Where
- France
- Volunteers
- 152 people
- Sponsor
- Laboratoires Thea
Neurotrophic Keratitis, Neurotrophic Keratopathy
Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis
Primary Objective: To assess the efficacy of cenegermin-bkbj (20 mcg/mL) ophthalmic solution on overall corneal thickness via AS-OCT in patients with stage 3 neurotrophic keratitis with respect to change from baseline at weeks 4…
- Conditions
- Neurotrophic Keratitis, Neurotrophic Keratopathy, Corneal Ulcer
- Trial name
- IMAGO (NCT06411145)
- Testing
- OXERVATE® 0.002%
- Sponsor
- Dompé Farmaceutici S.p.A
Neurotrophic Keratitis
Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 NK
The primary objective of this study is to evaluate the efficacy of 20 µg/ml 6 times a day of rhNGF eye drops solution (formulation containing anti-oxidant) compared to vehicle (formulation containing anti-oxidant) given 6 times a…
- Trial name
- NCT02227147
- Testing
- rhNGF 20µg/ml
- Where
- 12 sites in United States
- Volunteers
- 48 people
- Sponsor
- Dompé Farmaceutici S.p.A
Dry Eye
The THINK Study Incidence of Neurotrophic Keratopathy)
The study purpose is to evaluate corneal sensitivity in patients that have Stage 1 Neurotrphic Keratopathy (NK). Identifying patients with Stage 1 NK, may predict those who will in the future require rhNGF for optimal visual…
- Trial name
- THINK (NCT06482164)
- Testing
- Dry Eye Disease
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Research Insight LLC
Neurotrophic Keratopathy
Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in Subjects With Neurotrophic Keratopathy
The objective of this study is to evaluate the safety and effectiveness of OC-01 (varenicline) nasal spray as compared to placebo nasal spray for mean change from baseline in corneal fluorescein staining in subjects with Stage 1…
- Trial name
- NCT04957758
- Testing
- OC-01 (varenicline) nasal spray 1.2 mg/ml
- Where
- 31 sites in United States
- Volunteers
- 113 people
- Sponsor
- Oyster Point Pharma, Inc.