Efficacy of 20% Autologous Serum Drops in the Treatment of Corneal Epitheliopathy Associated With Antihypertensive Glaucoma Drops.

Introduction: Glaucoma is the second leading cause of blindness globally. Most anti-hypertensive drops contain preservatives harmful to the corneal epithelium, with up to 78% of treated patients reporting dry eye symptoms. Autologous serum eye drops (ASED), contains essential growth factors and nutrients which may promote corneal and conjunctival integrity, offering benefits over traditional treatments. This study investigates the efficacy of 20% ASED over placebo in the treatment of corneal epitheliopathies in patients with glaucoma treated with antihypertensive drops.

Methods: The present study is a triple-blinded, randomized controlled trial that anticipates to enroll 25 patients (50 eyes) with bilateral corneal epitheliopathy secondary to antihypertensive glaucoma treatments. Patients will receive autologous serum eye drops in one eye and placebo in the contralateral eye for two months, in addition to standard artificial tears treatment.

The primary outcome is the comparison of National Eye Institute (NEI) scores between autologous serum drops and placebo-treated eyes at two months. Secondary outcomes include Schirmer's test scores, visual acuity, tear break-up time (TBUT), Ocular Surface Disease Index (OSDI) scores, intraocular pressure, and complication rates.

The study aims to analyze the effectiveness of autologous serum eye drops in treating corneal epitheliopathies in glaucoma patients, potentially offering a new therapeutic avenue.

Study Overview

• Status: Not yet recruiting
• Conditions: Glaucoma; Dry Eye; Corneal Disease; Corneal Epitheliopathy
• Intervention / Treatment: Biological: 20% ASED + AT; Drug: 0.9% NS + AT

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Michaël Marchand-Gareau, MD; Phone Number: 71208 (819) 821-8000; Email: Michael.Marchand-Gareau@USherbrooke.ca
• Study Contact Backup: Name: Steven Bonneau, MD; Phone Number: 71208 (819) 821-8000; Email: Steven.Bonneau@usherbrooke.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients with glaucoma who developed corneal epitheliopathy secondary to antihypertensive drops;
• Epitheliopathy refractory to conventional therapies (Artificial Tears, ointment, topical cyclosporine or punctal plug, etc.);
• National Eye Institute score of 3 or more for both eyes;
• Adults aged 18 to 90 years inclusively.

Exclusion Criteria:

• Corneal epitheliopathy of other origin (ie. mechanical, neurotrophic, toxic, post-infectious, limbal stem cell deficiency);
• Glaucoma surgery within the last six (6) months;
• Previous corneal surgery;
• Active autoimmune disease;
• Frequent contact lense wear;
• Pregnant or actively breast-feeding;
• Known systemic infection with HIV, hepatitis B and C or syphilis;
• Known severe anemia (Hb < 100 g/L);
• Inability to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 20% Autologous serum eye drops + Artificial tear drops	Biological: 20% ASED + AT; Participants receive 20% Autologous Serum Eye Drops prepared by the hospital laboratory from the patients blood, diluted with sterile 0.9% sodium chloride to achieve the desired concentration. These drops are administered 6 times daily in one eye for two months. On top of this intervention is standard artificial tears therapy (Refresh Plus), applied four times daily.
Placebo Comparator: 0.9% NS eye drops + Artificial tear drops	Drug: 0.9% NS + AT; Participants in the placebo group receive eye drops consisting of sterile 0.9% sodium chloride solution, which serves as the placebo. The placebo solution is administered 6 times daily in one eye for two months. Alongside the placebo drops, participants continue with standard artificial tears therapy (Refresh Plus), applied four times daily throughout the study duration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Eye Index Scores	Compare NEI scores at 2 months between eyes treated with ASED 20% versus placebo in patients with corneal epitheliopathy secondary to antihypertensive glaucoma treatments.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schirmer Test	Compare Schirmer Test scores at 2 months between eyes treated with ASED 20% versus placebo in patients with corneal epitheliopathy secondary to antihypertensive glaucoma treatments.	2 months
Visual Acuity	Compare visual acuity at 2 months between eyes treated with ASED 20% versus placebo in patients with corneal epitheliopathy secondary to antihypertensive glaucoma treatments.	2 months
Tear Break Up Time	Compare tear break up time at 2 months between eyes treated with ASED 20% versus placebo in patients with corneal epitheliopathy secondary to antihypertensive glaucoma treatments.	2 months
Ocular Surface Disease Index	Compare ocular surface disease index scores at 2 months between eyes treated with ASED 20% versus placebo in patients with corneal epitheliopathy secondary to antihypertensive glaucoma treatments.	2 months
Intraocular Pressure	Compare intraocular pressure at 2 months between eyes treated with ASED 20% versus placebo in patients with corneal epitheliopathy secondary to antihypertensive glaucoma treatments.	2 months
Complication rates	Compare complications at 2 months between eyes treated with ASED 20% versus placebo in patients with corneal epitheliopathy secondary to antihypertensive glaucoma treatments.	2 months

Collaborators and Investigators

• Sponsor: Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Corneal Diseases
• Other Study ID Numbers: 2023-5009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No