Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06964269 · ClinicalTrials.gov registry record · Phase 4
Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease
A Phase 4 study of Dry Eye and Autoimmune Diseases, sponsored by Toyos Clinic.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06964269: Recruiting Phase 4 study of Dry Eye and Autoimmune Diseases, sponsored by Toyos Clinic.
NCT06964269 is a Phase 4 study of Dry Eye and Autoimmune Diseases that is actively recruiting participants, run by Toyos Clinic. The registered enrollment target is 20 participants, below the 95-participant average among 41 other Dry Eye trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06964269, a Phase 4 study of Dry Eye and Autoimmune Diseases, is actively recruiting participants, sponsored by Toyos Clinic.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
To assess the severity of injection comfort in the eyes. scale ranges from 0(none) - 100(severe)
Conditions Studied
Interventions
- DRUG Acthar Gel 80 UNT/ML Injectable Solution
Study Locations (1)
Tennessee
- Toyos Clinic - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-02-11 |
| Est. Completion | 2028-02-28 |
| Phase | Phase 4 |
What NCT06964269 shows while recruiting
NCT06964269 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 95-participant average among 41 other Dry Eye trials with a reported enrollment target (79% lower).
The record links to 3 conditions, with Dry Eye appearing as the primary indexed condition, and to 1 intervention - of which Acthar Gel 80 UNT/ML Injectable Solution is the first listed.
NCT06964269 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT06964269 about?
NCT06964269 is a clinical study titled "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 A...
What is the current status of trial NCT06964269?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2025-02-11. Estimated completion is 2028-02-28.
What conditions does trial NCT06964269 study?
This clinical trial studies the following conditions: Dry Eye, Autoimmune Diseases, Neurotrophic Keratitis.
What interventions are being tested in trial NCT06964269?
The interventions under investigation include: Acthar Gel 80 UNT/ML Injectable Solution (DRUG).
Who is sponsoring clinical trial NCT06964269?
This trial is sponsored by Toyos Clinic, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06964269 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dry Eye
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06964269's enrollment target sits among peer trials
20 35th of 41 higher than 4 of 41 other Dry Eye trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dry Eye trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Efficacy of Kera Sol Tears on Signs and Symptoms of Surgical Temporary Ocular Discomfort Syndrome (STODS) in Subjects Following LASIK
RECRUITING · Phase 4
-
Quality of Life in Presbyopic Patients Who Are Treated With Qlosi
RECRUITING · Phase 4
-
Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work
RECRUITING · Phase 4
-
Performance of Systane PRO Versus Refresh Optive Mega-3
RECRUITING · Phase 4
-
A Study to Evaluate Corneal Endothelial Cell Density (ECD) in Subjects With Dry Eye Disease (DED) Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months.
ACTIVE NOT RECRUITING · Phase 4
-
DOMPE -MT Neurotrophic Keratitis
ACTIVE NOT RECRUITING · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI