Clinical trials: Neurotrophic Keratopathy
Limbal Stem Cell Deficiency
Limbal Stem Cell Deficiency (LSCD) Treatment With Cultivated Stem Cell (CALEC) Graft
The main aim of the study is to determine the safety and feasibility of a cultivated autologous limbal epithelial cell (CALEC) transplantation in the treatment of limbal stem cell deficiency.
- Trial name
- CALEC (NCT02592330)
- Testing
- Biopsy to collect limbal epithelial stem cells that will be cultivated into a graft, Cultivation of Limbal epithelial cells into a graft, CALEC Transplant
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Massachusetts Eye and Ear Infirmary
Dry Eye, Neurotrophic Keratitis
DOMPE -MT Neurotrophic Keratitis
TITLE: Toyos Clinic / A Phase 4 Study to Assess Longer Duration of Treatment with Cenegermin in Moderate to Severe Dry Eye-Associated Neurotrophic Keratitis
- Trial name
- NCT06947850
- Testing
- Cenegermin Ophthalmic Solution [Oxervate]
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Toyos Clinic
Rare Diseases, Aniridia
Validation of Human Drugs Target of Repurposed Drugs and Novel Therapies
The cross-sectional observational clinical study related to rare eye diseases is a multi-center study in which the hypothesis is that neurokinin 1 receptor and/or substance P expression is increased in REDs associated with…
- Conditions
- Rare Diseases, Aniridia, Neurotrophic Keratopathy, Limbal Stem Cell Deficiency
- Trial name
- NCT06412718
- Volunteers
- 274 people, healthy volunteers welcome
- Sponsor
- IRCCS Ospedale San Raffaele
Corneal Epithelial Defect
Treatment of PED With AMT and Autologous Serum
Patients with persistent corneal epithelial defects who have not responded to conventional therapy will be randomized to treatment with either amniotic membrane transplantation or autologous serum 20%.
- Trial name
- NCT00238862
- Testing
- Amniotic membrane transplantation, Autologous serum/BSS 20%
- Where
- Saudi Arabia
- Volunteers
- 180 people
- Sponsor
- King Khaled Eye Specialist Hospital
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
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 Ulcer, Neurotrophic Keratitis
OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate
Neurotrophic keratitis (NK) is a condition where the cornea, or clear outer covering of the eye, has reduced sensation due to a variety of reasons.
- Conditions
- Neurotrophic Ulcer, Neurotrophic Keratitis, Neurotrophic Corneal Ulcer, Neurotrophic Keratoconjunctivitis
- Trial name
- NCT04573647
- Testing
- Cenegermin-Bkbj 0.002% Ophthalmic Solution [OXERVATE]
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Sight Medical Doctors PLLC
Neurotrophic Keratitis
Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy.
Many diseases can affect corneal nerves. Corneas that lack normal sensation are considered neurotrophic. Neurotrophic corneas are predisposed to persistent epithelial defects, recurrent erosions, and corneal ulcers.
- Trial name
- NCT05321251
- Testing
- Insulin, Tarsorrhaphy
- Where
- 6 sites in Canada
- Sponsor
- University of Alberta
Neurotrophic Keratitis
Nerve Growth Factor for the Treatment of Cornea Disease
To determine the efficacy and safety of nerve growth factor in the treatment of limbal stem cell deficiency (LSCD) associated with neurotrophic cornea.
- Trial name
- NCT04552730
- Testing
- Cenegermin-Bkbj
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Stanford University
Autoimmune Diseases, Dry Eye
Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease
Single-site, open label pilot study of 20 autoimmune patients diagnosed with dry eye demonstrating via the proparacaine challenge some peripheral corneal pain component.
- Conditions
- Autoimmune Diseases, Dry Eye, Neurotrophic Keratitis
- Trial name
- MNK (NCT06964269)
- Testing
- Acthar Gel 80 UNT/ML Injectable Solution
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Toyos Clinic
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
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
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.
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
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 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
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 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.
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
Miniinvasive Corneal Neurotization. A Pilot Study.
Neurotrophic keratitis (NK) is a degenerative disease of the cornea due to the impairment of the nasociliary branch of the ophthalmic nerve.
- Trial name
- MICORNE (NCT03037450)
- Testing
- Miniinvasive corneal neurotization
- Where
- France
- Volunteers
- 1 people
- Sponsor
- University Hospital, Strasbourg, France