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Topical Fibrinogen-Depleted Human Platelet Lysate in Patients With Dry Eye Secondary to Graft vs. Host Disease

NCT03414645 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-07-27

No results posted yet for this study

Summary

The purpose of this Phase 1/2 study is to compare the safety and tolerability of four times a day (QID) dosing of a non-preserved topical ocular drop formulation of 10 vol/vol % and 30 vol/vol % of FD hPL to vehicle control eye drops in patients with Dry Eye Disease (DED) secondary to Graft vs. Host Disease (GvHD).

Conditions

  • Dry Eye
  • Graft-versus-host-disease
  • Ocular Discomfort

Interventions

BIOLOGICAL

CAM-101 10%

fibrinogen-depleted human platelet lysate

BIOLOGICAL

Vehicle Control

PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop

BIOLOGICAL

CAM-101 30%

fibrinogen-depleted human platelet lysate

Sponsors & Collaborators

Principal Investigators

  • Edmund K Waller, MD PhD · Cambium Bio Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2019-12-12
Completion
2020-02-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03414645 on ClinicalTrials.gov