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Biological
Autologous platelet rich plasma eye drops for Dry Eye Syndrome
Phase 4
Waitlist Available
Research Sponsored by University Health Network, Toronto
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 at 6 and 12 weeks visit
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group
Summary
This trial is testing eye drops made from a patient's own blood to treat severe eye surface disease. It targets patients who don't respond well to standard treatments. The drops help heal the eye by providing essential growth factors and anti-inflammatory substances. These eye drops have been shown to be effective for the treatment of many eye diseases.
Eligible Conditions
- Dry Eye Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 and 12 weeks visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 and 12 weeks visit
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean change from baseline in Ocular Surface Disease Index (OSDI) score questionnaire
Secondary study objectives
Mean change from baseline of Corneo-conjunctival staining score
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment groupExperimental Treatment1 Intervention
Participant with moderate to sever ocular surface disease will be treated with autologous platelet rich plasma eye drops
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Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,519 Previous Clinical Trials
502,971 Total Patients Enrolled
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