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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1
Based on randomization d-MAPPS, will be self-administered, 2 drops into each eye four times a day (QID) a day for ninety (90) days.
Based on randomization, Placebo, will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.
Both the PI and the participant are masked on the drug administered.
Beverly Hills Institute of Ophthalmology
Beverly Hills, California, United States
RECRUITINGBeach Eye Medical Group
Huntington Beach, California, United States
RECRUITINGRegenerative Ocular Immunobiologics, LLC.
Palm Harbor, Florida, United States
Changes from Baseline utilizing University of North Carolina Dry Eye Management Scale (UNC DEMS) Scores
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.
Time frame: Through study completion, an average of 4 months.
Changes from Baseline utilizing Ocular Surface Disease Index (OSDI)
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.
Time frame: Through study completion, an average of 4 months.
Changes from baseline utilizing the NIH Eye Score for chronic oGVHD
The NIH Eye Score is a recommended measure, as it detects improvement or worsening in ocular chronic GVHD. Scoring from 0 to 3 is based on symptoms, need for eye drops, and use of therapeutic procedures or devices.
Time frame: Through study completion, an average of 4 months.
Changes from Baseline Oxford Schema for Corneal and Conjunctival Stain Grades
Oxford Schema for Corneal and Conjunctival Staining is a diagnostic test that looks for signs of damage or dryness in the eye. It involves a doctor applying dye to the eye to show areas of damage on its surface. The Oxford grading scale divides corneal staining into 6 groups according to severity: 0 = absent, I = minimal, II = mild, III = moderate, IV = marked, and V = severe. The changes will be evaluated from baseline and at timepoints 30 ±5 days, 60 ±5 days and 90±5 days.
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Glenn Eye Center
Lexington, Kentucky, United States
RECRUITINGEyewell, LLC.
Boston, Massachusetts, United States
RECRUITINGTime frame: Through study completion, an average of 4 months.