A Double-Masked, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of d-MAPPS™ Ophthalmic Solution in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)
Overview
- Phase
- Phase 1
- Intervention
- d-MAPPS
- Conditions
- Not specified
- Sponsor
- Regenerative Ocular Immunobiologics LLC
- Enrollment
- 1
- Locations
- 10
- Primary Endpoint
- Changes from Baseline utilizing University of North Carolina Dry Eye Management Scale (UNC DEMS) Scores
- Status
- Recruiting
- Last Updated
- 15 days ago
Overview
Brief Summary
A Double-Masked, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of d-MAPPS™ Ophthalmic Solution in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGHVD)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years.
- •Willing and able to provide written informed consent.
- •Willing and able to comply with study assessments for the full duration of the study.
- •Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at the time of accrual.
- •Minimum Oxford Schema grad of ≥ 1 in at least one eye.
- •OSDI scored of ≥
- •UNC DEMS score of ≥
- •In good stable overall health.
Exclusion Criteria
- •History of Rheumatoid Arthritis, Lupus, Scleroderma.
- •Ocular or periocular malignancy.
- •Significant change, as judged by the principal investigator, in systemic immunosuppressive regimen within 2 weeks of study entry.
- •Any history of topical tacrolimus use.
- •Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month.
- •Any change in frequency of preserved anti-glaucoma medications within 2 weeks of study entry.
- •Current use of topical steroids more than twice a day.
- •Corneal epithelial defect \> 1mm
- •Any history of herpetic keratitis.
- •Participation in another simultaneous medical research study.
Arms & Interventions
This arm randomizes the actual drug to the patient.
Based on randomization, d-MAPPS™ will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.
Intervention: d-MAPPS
This arm randomizes the placebo to the patient.
Based on randomization Placebo/sterile water, will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.
Intervention: Placebo
Both patient and PI are masked.
Upon acceptance into the study, the sponsor will be notified, and the patient will be randomized to the treatment or placebo arm. Randomization Code Key will have limited access to only authorized personnel. Based on the results of the randomization selection, the sponsor will provide the appropriate subject number and lot coded eyedropper bottles containing d-MAPPS™ or Placebo/sterile water to the doctor for dissemination.
Intervention: d-MAPPS
Both patient and PI are masked.
Upon acceptance into the study, the sponsor will be notified, and the patient will be randomized to the treatment or placebo arm. Randomization Code Key will have limited access to only authorized personnel. Based on the results of the randomization selection, the sponsor will provide the appropriate subject number and lot coded eyedropper bottles containing d-MAPPS™ or Placebo/sterile water to the doctor for dissemination.
Intervention: Placebo
Both patient and PI are masked.
Upon acceptance into the study, the sponsor will be notified, and the patient will be randomized to the treatment or placebo arm. Randomization Code Key will have limited access to only authorized personnel. Based on the results of the randomization selection, the sponsor will provide the appropriate subject number and lot coded eyedropper bottles containing d-MAPPS™ or Placebo/sterile water to the doctor for dissemination.
Intervention: PI and Patient Masked
Outcomes
Primary Outcomes
Changes from Baseline utilizing University of North Carolina Dry Eye Management Scale (UNC DEMS) Scores
Time Frame: Through study completion, an average of 4 months.
The UNC Dry Eye Management Scale (DEMS) helps evaluate different aspects of DED, including symptoms, severity, and impact on daily life. Dry eye symptoms such as grittiness, dryness, foreign body sensation, redness, tearing, and irritation. The UNC DEMS is used in clinical settings to inform treatment decisions and monitor the effectiveness of interventions. UNC DEMS scores are on a scale from 1-10, with 10 being the most severe. The changes will be evaluated from baseline and at timepoints 30 ±5 days, 60 ±5 days and 90 ±5 days.
Changes from Baseline utilizing Ocular Surface Disease Index (OSDI)
Time Frame: Through study completion, an average of 4 months.
Ocular Surface Disease Index (OSDI) Questionnaire is a 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate each of the dry eye symptoms on a 0-4 scale. The results are calculated in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms. The changes will be evaluated from baseline and at timepoints 30 ±5 days, 60 ±5 days and 90 ±5 days.
Secondary Outcomes
- Changes from baseline utilizing the NIH Eye Score for chronic oGVHD(Through study completion, an average of 4 months.)
- Changes from Baseline Oxford Schema for Corneal and Conjunctival Stain Grades(Through study completion, an average of 4 months.)