NCT04608084

Brief Summary

The purpose of this study is to evaluate prospectively the efficacy of topical administration of autologous platelet rich plasma as monotherapy for the treatment of symptoms and clinical signs in cases affected by moderate to severe forms of ocular surface disease

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

October 22, 2020

Last Update Submit

October 22, 2020

Conditions

Ocular Surface DiseaseDry Eye Syndromes

Keywords

Dry eye syndromePlatelet rich plasmaocular surface diseaseAutologous serum

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline in Ocular Surface Disease Index (OSDI) score questionnaire

    The OSDI assesses quality of life measures of ocular surface disease symptoms which aligns the questionnaire with Federal Food and Drug Administration's emphasis on utilizing patient-reported outcomes in order to support medicinal product submissions and clinical drug trial efficacy

    At 6 and 12 weeks visit

Secondary Outcomes (1)

  • Mean change from baseline of Corneo-conjunctival staining score

    At 6 and 12 weeks visit

Study Arms (1)

Treatment group

EXPERIMENTAL

Participant with moderate to sever ocular surface disease will be treated with autologous platelet rich plasma eye drops

Biological: Autologous platelet rich plasma eye drops

Interventions

Autologous platelet rich plasma eye dropsBIOLOGICAL

Participant own blood is used for the preparation of Autologous platelet rich plasma eye drops

Treatment group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: prospective
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

October 22, 2020

First Posted

October 29, 2020

Study Start

January 1, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

October 29, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)