Viewing Study NCT04608084



Ignite Creation Date: 2024-05-06 @ 3:22 PM
Last Modification Date: 2024-10-26 @ 1:48 PM
Study NCT ID: NCT04608084
Status: UNKNOWN
Last Update Posted: 2020-10-29
First Post: 2020-10-22

Brief Title: Platelet Rich Plasma Eye Drops for Treatment of Ocular Surface Disease
Sponsor: University Health Network Toronto
Organization: University Health Network Toronto

Study Overview

Official Title: Platelet Rich Plasma Eye Drops for Treatment of Ocular Surface Disease
Status: UNKNOWN
Status Verified Date: 2020-10
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: Background Ocular Surface Disease OSD is a multifactorial disease of the ocular surface and tears that produce symptoms of discomfort visual disturbance and tear film instability with potential damage to the ocular surface It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface The prevalence of Ocular surface disease reported in the literature up to 30 of the elderly population There are two main mechanisms that explain this ocular surface dysfunction aqueous deficiency and excessive evaporation of the tear film The aqueous deficient dry eye disease is characterized by an insufficient volume of tears due to dysfunction of the lacrimal glands and obstruction of the lacrimal ducts This mechanism is also related to autoimmune diseases such as Sjogrens syndrome Lupus and Rheumatoid arthritis Meibomian gland dysfunction eyelid problems infrequent blinking entropion ectropion are typical causes of evaporative dry eye Poor tear film quality is the result of tear hyperosmolarity and goblet cell mucin deficiency Ocular surface disease can also arise as iatrogenic complication after external or internal ocular surgery laser treatment radiation chemotherapy or ocular medications

Treating ocular surface diseases can be challenging and treatment usually depends on the underlining etiology and can be divided into medical treatment and surgical solutions Non preserved artificial tears are usually the first line treatment for OSD associated with aqueous deficiency and anti-inflammatory drops like steroids lifitegrast 5 Xiidra-shire and cyclosporin 005 Restasis - allergan often accompanied for treating the underling inflammatory process However none of these treatment includes essential tear components such as growth factors vitamins and immunoglobulins

Hemoderivatives drops such as autologous serum AS have been recommended for the treatment of several ocular surface disturbances such as Sjögrens syndrome-related tear deficiency non-Sjögrens tear deficiency associated with graft-versus-host disease neurotrophic keratitis persistent epithelial defects superior limbic keratoconjunctivitis as well as a supportive measure in ocular surface reconstruction

Platelet rich plasma PRP has been reported as successful treatments for moderate to severe OSD caused by dry eye presenting advantages over AS due to its richer concentration of growth factors anti-inflammatory cytokines and other platelet derivatives The high concentration of platelets obtained through a relatively simple process which requires minimal manipulation and no addition of any other substance

studies have shown that these components help in the proliferation migration and differentiation of corneal epithelial cells which is beneficial for the required ocular surface restoration in moderate to severe forms of OSD

Investigated product Name Autologous Platelet rich plasma Indications Ocular surface diseases

Preparation and handling

For preparation of autologous PRP eye drops dedicated closed system ECLIPSE PRP PLATELET PREPARATION SYSTEM which is health Canada approved will be used

peripheral blood from participants own antecubital vein will be collected into 12 mL tube then it will be centrifuged at 580 g for 8 min at room temperature in an Eclipse System centrifuge ECLIPSE EASY SPIN

The whole column of PRP will be collected after centrifugation avoiding the buffy coat that contains the leukocytes using a sterile 10ml syringe then the product is divided into 10 vials of 1ml each through a closed system The vials will be given to the patient in a sealed box with ice packs

Methodology Patient selection Inclusion criteria Potential patients diagnosed with OSD will be identified at Dr Slomovics Cornea clinic at Toronto Western Hospital Patients will be included when the fluorescein corne-conjunctival staining score is 5 or more as determined by NEIIndustry Grading System17 and OSDI questionnaire score of 20 or more after treatment with non-preserved artificial tears 4day for at least 1 month

Patients will be excluded when they are under the age of 18 years or incapacitated patients

If both eyes in one patient meet the inclusion criteria the eye with higher corneal fluorescein staining score will be enrolled and analyzed for the study although both eyes will be subject to treatment If both eyes have the same score the right eye will be enrolled

For the purpose of this study 100 participants will be enrolled Main steps of the study Step 1 Recruitment consenting the participant Step 2 Baseline evaluation and PRP preparation visit Step 3 Treatment effect monitoring visit 6 weeks post treatment initiation Step 4 Follow-up visit 6 weeks post treatment completion

Recruitment consenting the participant Following clinical evaluation the ophthalmologist decides if the patient meets the study criteria If the prospective participant is eligible and interested in the project a qualified member of the team will explain the benefits and risks of the trial and obtain informed consent the patient will have the right to refuse participating in the study and will have time to ask questions regarding the study Patient could advice his family and friends before signing the informed consent patient will have no time limit for signing the informed consent

Baseline 6-week and 12 weeks assessment Prior to baseline assessment informed consent will be obtained

At baseline after 6 weeks of treatment and 6 weeks post finishing the treatment The following will be examined

1 Subjective dry eye symptoms as assessed by the Ocular Surface Disease Index OSDI questionnaire
2 The noninvasive tear film break-up time TFBUT
3 Aqueous tear secretion as evaluated by Schirmer I test
4 Corneo-conjunctival staining scores graded by NEIIndustry Grading System after 1 fluorescein dye staining
5 Keratograph 5M Oculus Wetzlar Germany
6 Tear film osmolarity with a lab-on-a-chip technique TearLab TearLab Corporation San Diego CA USA
7 Central corneal sensitivity test by Cochet-Bonnet esthesiometer

At the 6-weeks visit participant will be asked to answer a compliance questionnaire

Treatment The enrolled participants will commence topical application of autologous PRP drops 4 times per day for 6 weeks

Administration of any other topical medications treating the patient ocular surface will not be allowed during the study period

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None