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NCT03414645 · ClinicalTrials.gov registry record · Phase 1
Topical Fibrinogen-Depleted Human Platelet Lysate in Patients With Dry Eye Secondary to Graft vs. Host Disease
A Phase 1 study of Graft-Versus-Host Disease and Dry Eye, sponsored by Cambium Bio Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 6
- Study locations
NCT03414645: Completed Phase 1 study of Graft-Versus-Host Disease and Dry Eye, sponsored by Cambium Bio Limited.
NCT03414645 is a Phase 1 study of Graft-Versus-Host Disease and Dry Eye that has completed, run by Cambium Bio Limited. The registered enrollment target is 64 participants, below the 81-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (21% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03414645, a Phase 1 study of Graft-Versus-Host Disease and Dry Eye, has completed, sponsored by Cambium Bio Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 6
- Study locations
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).
Primary Outcome
To evaluate the safety and tolerability of two concentrations of CAM-101 (FD hPL 10 vol/vol % and 30 vol/vol %) topical ophthalmic solution in patients with dry eye disease (DED) secondary to graft versus host disease (GvHD) after 6 weeks (42 days) of treatment. The primary outcome measure: Percentage of patients in each dose group with ocular adverse events at Day 42
Conditions Studied
Interventions
- BIOLOGICAL CAM-101 10%
- BIOLOGICAL Vehicle Control
- BIOLOGICAL CAM-101 30%
Study Locations (6)
California
- Byers Eye Institute of Stanford University - Palo Alto
Massachusetts
- Massachusetts Eye and Ear Infirmary - Boston
Michigan
- University of Michigan - Kellogg Clinical Research Center - Ann Arbor
Minnesota
- University of Minnesota - Minneapolis
North Carolina
- Duke University Eye Center - Durham
Oregon
- Oregon Health Sciences University - Casey Eye Institute - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2020-02-20 |
| Phase | Phase 1 |
What the finished NCT03414645 record still lists
NCT03414645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 81-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (21% lower).
The record links to 3 conditions, with Graft-Versus-Host Disease appearing as the primary indexed condition, and to 3 interventions - of which CAM-101 10% is the first listed.
NCT03414645 lists 6 locations in 6 states (California, Massachusetts, Michigan).
Frequently Asked Questions
What is clinical trial NCT03414645 about?
NCT03414645 is a clinical study titled "Topical Fibrinogen-Depleted Human Platelet Lysate in Patients With Dry Eye Secondary to Graft vs. Host Disease". 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...
What is the current status of trial NCT03414645?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2018-05-01. Estimated completion is 2020-02-20.
What conditions does trial NCT03414645 study?
This clinical trial studies the following conditions: Graft-Versus-Host Disease, Dry Eye, Ocular Discomfort.
What interventions are being tested in trial NCT03414645?
The interventions under investigation include: CAM-101 10% (BIOLOGICAL), Vehicle Control (BIOLOGICAL), CAM-101 30% (BIOLOGICAL).
Who is sponsoring clinical trial NCT03414645?
This trial is sponsored by Cambium Bio Limited, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03414645 being conducted?
This trial has 6 study locations across California, Massachusetts, Michigan, Minnesota, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03414645's enrollment target sits among peer trials
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