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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06294015
• Other study ID #: 2023-5009
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 2024
• Est. completion date: April 2026

Study information

• Verified date: February 2024
• Source: Université de Sherbrooke
• Contact: Michaël Marchand-Gareau, MD
• Phone: (819) 821-8000
• Email: Michael.Marchand-Gareau[@]USherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: April 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Corneal Disease
• Corneal Diseases
• Dry Eye
• Glaucoma

Intervention

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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