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

Phase 4

Not yet recruiting

• Conditions: Corneal Disease; Corneal Epitheliopathy; Glaucoma; Dry Eye
• Interventions: Biological: 20% ASED + AT; Drug: 0.9% NS + AT

• Registration Number: NCT06294015
• Lead Sponsor: Université de Sherbrooke

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-31
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-27
• Last Update Submitted: 2024-02-27
• Study Start: 2024-03
• Study First Posted: 2024-03-05
• Last Update Posted: 2024-03-05
• Primary Completion: 2025-12
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
20% Autologous serum eye drops + Artificial tear drops	20% ASED + AT	-
0.9% NS eye drops + Artificial tear drops	0.9% NS + AT	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index	2 months	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.
Intraocular Pressure	2 months	Compare intraocular pressure at 2 months between eyes treated with ASED 20% versus placebo in patients with corneal epitheliopathy secondary to antihypertensive glaucoma treatments.
Complication rates	2 months	Compare complications at 2 months between eyes treated with ASED 20% versus placebo in patients with corneal epitheliopathy secondary to antihypertensive glaucoma treatments.
Visual Acuity	2 months	Compare visual acuity at 2 months between eyes treated with ASED 20% versus placebo in patients with corneal epitheliopathy secondary to antihypertensive glaucoma treatments.
Tear Break Up Time	2 months	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.
Schirmer Test	2 months	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.