Clinical trial NCT06294015: Efficacy of 20% Autologous Serum Drops in the Treatment of Corneal Epitheliopathy Associated With Antihypertensive Glaucoma Drops.
Official title: Efficacy of 20% Autologous Serum Drops in the Treatment of Corneal Epitheliopathy Associated With Antihypertensive Glaucoma Drops.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Corneal Epitheliopathy
Glaucoma
Corneal Disease
Dry Eye
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: National Eye Index Scores
timeFrame: 2 months
Secondary outcomes:
measure: Schirmer Test
timeFrame: 2 months
measure: Visual Acuity
timeFrame: 2 months
measure: Tear Break Up Time
timeFrame: 2 months
measure: Ocular Surface Disease Index
timeFrame: 2 months
measure: Intraocular Pressure
timeFrame: 2 months
measure: Complication rates
timeFrame: 2 months
Other outcomes:
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