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Platelet Lysate
CAM-101 30% for Dry Eye Syndrome
Phase 1 & 2
Waitlist Available
Research Sponsored by Cambium Medical Technologies LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days
Awards & highlights
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).
Eligible Conditions
- Dry Eye Syndrome
- Eye Discomfort
- Graft-versus-Host Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with ocular treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with systemic treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary outcome measures
Efficacy as measured by change in corneal staining
Efficacy as measured by ocular discomfort using the 100 point visual analogue scale (VAS) scores
Efficacy as measured by ocular surface disease index (OSDI)
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: CAM-101 30%Experimental Treatment1 Intervention
FD hPL 30 vol/vol %
Group II: CAM-101 10%Experimental Treatment1 Intervention
FD hPL 10 vol/vol %
Group III: Vehicle ControlPlacebo Group1 Intervention
PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CAM-101 10%
2018
Completed Phase 2
~70
CAM-101 30%
2018
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
Cambium Medical Technologies LLCLead Sponsor
Oregon Health and Science UniversityOTHER
994 Previous Clinical Trials
7,386,884 Total Patients Enrolled
University of MichiganOTHER
1,833 Previous Clinical Trials
6,423,064 Total Patients Enrolled
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