Corneal EpitheliopathyPhase 4NCT06294015
Efficacy of 20% Autologous Serum Drops in the Treatment of Corneal Epitheliopathy Associated With Antihypertensive Glaucoma Drops.
A Phase 4 study testing 20% ASED + AT and 0.9% NS + AT in people with Corneal Epitheliopathy and Glaucoma, run by Université de Sherbrooke.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Epitheliopathy, Glaucoma, Corneal Disease
- What is being tested?
- 20% ASED + AT and 0.9% NS + AT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Known systemic infection with HIV, hepatitis B and C or syphilis;
- Known severe anemia (Hb < 100 g/L);
- Inability to give informed consent
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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
- Being tested
- 20% ASED + AT, 0.9% NS + AT
- Medical subject headings
- Glaucoma, Corneal Diseases, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20% ASED + ATBiological
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 + ATDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 20% Autologous serum eye drops + Artificial tear drops | Experimental | Not described Receives: Biological: 20% ASED + AT |
| 0.9% NS eye drops + Artificial tear drops | Placebo comparator | Not described Receives: Drug: 0.9% NS + AT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (6)
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EpitheliopathyStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294015
- Sponsor's protocol ID
- 2023-5009
- Status last verified
- Feb 2024
- First submitted
- 31 Jan 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 20% Autologous Serum Drops in the Treatment of Corneal Epitheliopathy Associated With Antihypertensive Glaucoma Drops.
- ClinicalTrials.gov ID
- NCT06294015
- Acronym / sponsor ID
- 2023-5009
- Conditions
- Corneal Epitheliopathy, Glaucoma, Corneal Disease, Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20% ASED + ATParticipants 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. | Biological | 20% Autologous serum eye drops + Artificial tear drops |
| 0.9% NS + ATParticipants 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. | Drug | 0.9% NS eye drops + Artificial tear drops |
Primary outcome
National Eye Index Scores
Time frame: 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.
6 secondary outcomes
Schirmer Test
Time frame: 2 months
Visual Acuity
Time frame: 2 months
Tear Break Up Time
Time frame: 2 months
Ocular Surface Disease Index
Time frame: 2 months
Intraocular Pressure
Time frame: 2 months
Complication rates
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 20% ASED + AT and 0.9% NS + AT in people with Corneal Epitheliopathy and Glaucoma, run by Université de Sherbrooke.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michaël Marchand-Gareau, MD ((819) 821-8000 ext. 71208, Michael.Marchand-Gareau@USherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Eye Index Scores (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.