Clinical Research Directory

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). The study plans to enroll 48 patients with Mackie Stage 2 or 3 NK affecting one or both eyes. Eligible subjects will be randomized 1:1:1 into three dosing groups. Each dosing group will follow a drug-placebo allocation (12 active: 4 placebo). Treatment involves topical ocular administration for 8 weeks. Subjects who are not healed after the 8 weeks of masked treatment period will be permitted to receive standard of care during the follow-up period

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 with Stage 2 or 3 neurotrophic keratitis (NK) via topical application. This is a Phase 1/2, multicenter, double-masked, placebo-controlled study to evaluate the safety, tolerability, and preliminary efficacy of KB801 in these subjects.

Corneal Neurotization vs. Cenergermin for Neurotrophic Keratitis: A Pilot Study

This pilot study evaluates the feasibility and outcomes of two treatment approaches for corneal sensory dysfunction due to neurotrophic keratitis (NK): corneal neurotization surgery and topical Cenergermin (Oxervate). Participants will receive treatment based on clinical decision-making, not randomization, and will be followed for 12 months through eight visits at the Ivey Eye Institute, St. Joseph's Health Care London. Data collected during routine eye examinations and validated quality-of-life questionnaires will be used to assess visual outcomes, corneal structure and function, and patient-reported well-being. This feasibility study is funded by the Lawson Research Institute Internal Research Fund and is intended to generate preliminary evidence for a future randomized trial.

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. At least 16 patients will receive and complete 12 weeks of 80 units of Acthar Gel to be injected subcutaneously twice weekly via Acthar Gel single-dose pre-filled SelfJectTM injector (SelfJect) to assess the effects on subjective sensation of ocular pain, conjunctival and corneal staining, in vivo assessments of corneal nerves as measured by confocal imaging, VAS scales of common neuropathic pain symptoms and comfort of SelfJect will be assessed.

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

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. The study plans to enroll 80 healthy subjects and is divided into three stages: the single-dose study stage, the multiple-dose study stage, and the tear PK study stage. The single-dose and multiple-dose study stages are randomized, double-blind, placebo-controlled, dose-escalation designs, while the tear PK study stage is a single-dose, open-label design.

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.

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. In more advanced cases of NK, the cornea can develop an area of thinning called an ulcer. The purpose of this research is to find out if Oxervate (cenegermin-bkbj 0.002%) an FDA-approved treatment for neurotrophic corneal ulcers leads to an increase in thickness of the corneal stroma (middle layer of the cornea) during and after treatment of a neurotrophic ulcer. Corneal thickness will be measured using optical coherence tomography (OCT), a non-contact imaging device used routinely in ophthalmology examinations. Corneal sensation will also be measured during and after treatment with a device called a Cochet-Bonnet esthesiometer to see if the treatment increases corneal sensation.