CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 64 enrolled / 64 target
Drug / intervention
CAM-101 10% +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03414645
NCT03414645Phase 1CompletedMonitor (0.7/mo)Completion was 78mo ago
CompareCT.gov

Randomized Multicenter Double-Masked Placebo-Controlled Parallel Phase I/II Study to Determine the Safety and Exploratory Efficacy of Topical Fibrinogen Depleted Human Platelet Lysate in Patients With Dry Eye Secondary to Graft vs Host Disease

Cambium Bio Limited·interventional·Posted Jan 30, 2018·Updated Jun 12, 2026

In Brief

A Phase 1 clinical trial evaluating CAM-101 10%, Vehicle Control, and 1 other intervention for Dry Eye and 2 related conditions. Completed, enrolled 64 participants across 6 sites.

Signals

Enrolling slower than its timeline implies

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye, Graft-versus-host-disease, Ocular Discomfort
CountriesUnited States
CollaboratorsMassachusetts Eye and Ear Infirmary, Oregon Health and Science University, University of Michigan, Duke University, Stanford University, University of Minnesota

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJan 30, 2018
Enrollment StartMay 1, 2018
Primary CompletionDec 12, 2019
Study CompletionFeb 20, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.4 years ago

Arms & Interventions

CAM-101 10%experimental

FD hPL 10 vol/vol %

Biological: CAM-101 10%
CAM-101 30%experimental

FD hPL 30 vol/vol %

Biological: CAM-101 30%
Vehicle Controlplacebo_comparator

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

Biological: Vehicle Control

Interventions

CAM-101 10%biological

fibrinogen-depleted human platelet lysate

Vehicle Controlbiological

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

CAM-101 30%biological

fibrinogen-depleted human platelet lysate