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

Conditions

• Ocular Graft Versus Host Disease
• oGVHD

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• d-MAPPS™ Ophthalmic Solution — BIOLOGICAL
  Sterile, preservative-free ophthalmic solution administered as two drops into each eye four times daily for 90 consecutive days.
• Matching vehicle control — BIOLOGICAL
  Matching vehicle control supplied in identical masked containers and administered as two drops into each eye four times daily for 90 consecutive days.

Study Details

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.

Key Dates

First listed

Aug 20, 2026

Start date

Sep 30, 2026

Status verified

Sep 2026

Primary completion

Mar 31, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Vehicle Controlled
• Experimental: Active Study Drug

Primary Outcome Measure

Change From Baseline to Day 90 in Modified Oxford Corneal Staining Score [ Time Frame: Baseline to Day 90 (±5 days) ]

Central Contacts

• Marissa Harrell, PhD
  727-748-0420
  [email protected]

Locations (5)

Find similar trials in Beverly Hills, CA

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