drugset / Trial / NCT03414645
Topical Fibrinogen-Depleted Human Platelet Lysate in Patients With Dry Eye Secondary to Graft vs. Host Disease
Phase 1/2
Completed
64 enrolled
Cambium Bio Limited
Duke University · collabMassachusetts Eye and Ear Infirmary · collabOregon Health and Science University · collabStanford University · collabUniversity of Michigan · collabUniversity of Minnesota · collab
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2018-05-01
- Primary completion
- 2019-12-12
- Completion
- 2020-02-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CAM-101 | Unknown | 10 % | Topical |
| Subject | CAM-101 | Unknown | 30 % | Topical |