Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| This arm randomizes the actual drug to the patient. | Active Comparator | Based on randomization, d-MAPPS™ will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days. |
|
| This arm randomizes the placebo to the patient. | Placebo Comparator | Based on randomization Placebo/sterile water, will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days. |
|
| Both patient and PI are masked. | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| d-MAPPS | Biological | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Through study completion, an average of 4 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 4 months. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills Institute of Ophthalmology | Beverly Hills | California | 90210 | United States | ||
| Beach Eye Medical Group |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Biological | Based on randomization, Placebo, will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days. |
|
| PI and Patient Masked | Other | Both the PI and the participant are masked on the drug administered. |
|
| 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. |
| Through study completion, an average of 4 months. |
| Huntington Beach |
| California |
| 92648 |
| United States |
| Regenerative Ocular Immunobiologics, LLC. | Palm Harbor | Florida | 34684 | United States |
| Glenn Eye Center | Lexington | Kentucky | 40511 | United States |
| Eyewell, LLC. | Boston | Massachusetts | 02215 | United States |
| BostonSight | Boston | Massachusetts | 02494 | United States |