Study of d-MAPPS™ Ophthalmic Solution in Adults With Chronic Ocular Graft-Versus-Host Disease (oGVHD)

Condition(s) studied

Investigational drug(s) / intervention(s)

d-MAPPS™ Ophthalmic Solution: Sterile, preservative-free ophthalmic solution administered as two drops into each eye four times daily for 90 consecutive days.

Matching vehicle control: Matching vehicle control supplied in identical masked containers and administered as two drops into each eye four times daily for 90 consecutive days.

Study summary

This is a Phase III, multicenter, randomized, double-masked, vehicle-controlled, parallel-group clinical trial designed to evaluate the efficacy, safety, and tolerability of d-MAPPS™ Ophthalmic Solution in adult subjects with chronic ocular graft-versus-host disease (oGVHD). Eligible subjects will receive masked study treatment for 90 days, with the primary efficacy assessment performed at the Day 90 study visit.

Eligibility

Primary outcome measure(s)

• Change From Baseline to Day 90 in Modified Oxford Corneal Staining Score — Baseline to Day 90 (±5 days)
  Corneal fluorescein staining will be assessed in the prespecified study eye using the Modified Oxford grading scale. Scores range from 0 to 5, where 0 represents no corneal staining and higher scores represent progressively greater staining. A decrease from Baseline indicates improvement.
• Change From Baseline to Day 90 in Ocular Surface Disease Index (OSDI) Total Score — Baseline to Day 90 (±5 days)
  The Ocular Surface Disease Index (OSDI) will assess ocular symptoms and their effect on vision-related functioning. Total scores range from 0 to 100, with higher scores representing greater symptom burden. A decrease from Baseline indicates improvement.

Trial sites (5)

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