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

NCT06294015 | Not Yet Recruiting Phase 4

• 1 other identifier: 2023-5009
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Schirmer Test

  2 months

• Visual Acuity

  2 months

• Tear Break Up Time

  2 months

• Ocular Surface Disease Index

  2 months

• Intraocular Pressure

  2 months

Study Arms (2)

20% Autologous serum eye drops + Artificial tear drops

EXPERIMENTAL

Biological: 20% ASED + AT

0.9% NS eye drops + Artificial tear drops

PLACEBO COMPARATOR

Drug: 0.9% NS + AT

Interventions

20% ASED + AT 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.

20% Autologous serum eye drops + Artificial tear drops

0.9% NS + AT 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.

0.9% NS eye drops + Artificial tear drops

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

MeSH Terms

Conditions

Glaucoma; Corneal Diseases; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Lacrimal Apparatus Diseases

Central Study Contacts

Michaël Marchand-Gareau, MD

CONTACT

(819) 821-8000; Michael.Marchand-Gareau@USherbrooke.ca

Steven Bonneau, MD

CONTACT

(819) 821-8000; Steven.Bonneau@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: March 5, 2024
• Study Start: March 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: March 5, 2024

Record last verified: 2024-02