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

NCT ID: NCT06294015

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2026-04-30

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.

Conditions

Corneal Epitheliopathy; Glaucoma; Corneal Disease; Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

20% Autologous serum eye drops + Artificial tear drops

Group Type: EXPERIMENTAL

20% ASED + AT

Intervention Type: BIOLOGICAL

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.

0.9% NS eye drops + Artificial tear drops

Group Type: PLACEBO_COMPARATOR

0.9% NS + AT

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Michaël Marchand-Gareau, MD

Role: CONTACT

Michael.Marchand-Gareau@USherbrooke.ca

(819) 821-8000 ext. 71208

Steven Bonneau, MD

Role: CONTACT

Steven.Bonneau@usherbrooke.ca

(819) 821-8000 ext. 71208

Other Identifiers

2023-5009

Identifier Type: -

Identifier Source: org_study_id