Efficacy and Safety of 20% and 100% Autologous Serum Eye Drops in Patients With Severe Dry Eye Disease: a Prospective, Blinded, Randomized, Crossover Study
Study tests own blood serum drops for severe dry eye
Plain English Summary
Efficacy and Safety of 20% and 100% Autologous Serum Eye Drops in Patients With Severe Dry Eye Disease (AST) is a Not Applicable clinical trial sponsored by University Hospital, Ghent studying Dry Eye Disease. This study tested if eye drops made from a patient's own blood serum (at 20% and 100% concentration) are effective and safe for treating severe dry eye disease. It is for adults (18+) with severe dry eye symptoms that haven't responded well to other treatments and show specific signs of eye surface damage. Participants received three different treatments over 8 weeks each: preservative-free artificial tears, 20% serum drops, and 100% serum drops, with a 2-week break between each treatment. Alternatives include standard artificial tears, prescription eye drops, punctal plugs, and lifestyle changes, though this study focuses on a specific type of serum drop. The trial aims to enroll 46 participants.
Official Summary
A prospective, single-blinded, randomized, controlled crossover trial was conducted in patients with severe dry eye syndrome. Topical treatment with autologous serum eye drops (ASED) diluted at 20%, undiluted ASED and conventional preservative-free artificial tears (PFAT) were compared as a treatment for severe dry eye disease. The primary outcome measure was assessment of ocular symptoms using the Ocular Surface Disease Index (OSDI) questionnaire. Secondary outcomes were Schirmer 1 test, best-corrected visual acuity (BVCA), corneal fluorescein and conjunctival lissamine green staining using the Sjögren's International Collaborative Clinical Alliance Ocular Surface Staining (SICCA OSS) score, tear break up time (TBUT), conjunctival injection score (CIS) and Meibomian gland dysfunction (MGD) grading. Additionally, serum and tear cytokine analysis and microbiological cultures were performed.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with severe dry eye. Patients must have significant dry eye symptoms (OSDI score > 33) and at least one objective sign of eye damage like poor tear film, corneal staining, or low tear production. Individuals unable to complete the study, understand Dutch, have a history of not following treatment, severe anemia, known allergies to the treatment, or are pregnant cannot participate. The investigator also has the final say on whether a patient is suitable for the study. This trial is studying Dry Eye Disease, so participants generally need a confirmed diagnosis.
What They're Measuring
The main goal is to see if using eye drops made from your own blood serum improves your dry eye symptoms, as measured by a standard questionnaire about how your eyes feel. The specific primary outcome measures are: Change from baseline in participant-reported severity and/or frequency of dry eye-related symptoms based on a validated patient symptom questionnaire (Ocular Surface Disease Index questionnaire, OSDI) (8 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial addresses a gap in treatment for severe dry eye by investigating the potential of autologous serum eye drops, which may offer a more natural and personalized approach for patients who don't This research targets Dry Eye Disease, where improved treatment options are needed.
Investor Insight
This study explores a personalized treatment for a common and often debilitating condition, potentially offering a new therapeutic option in the dry eye market, though its commercial viability depends
Is This Trial Right for Me?
Ask your doctor about the specific benefits and risks of using your own serum for eye drops, and how it compares to other treatments. Be prepared for regular visits to the hospital for assessments and to receive the different treatments. The study involves applying different types of eye drops for 8 weeks at a time, with short breaks in between, and undergoing various eye tests. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: CROSSOVER
- Masking: DOUBLE
- Enrollment: 46 participants
Interventions
- DRUG: Preservative-free artificial tears — Each patient received three 8-week treatments in a randomized sequence, being PFAT, AS 20% and AS 100%. After 8 weeks of treatment, the treatment effect was evaluated during a scheduled study visit. The patient was then instructed to start a new washout of 2 weeks to immediately follow with the next treatment.
- DRUG: Autologous serum eyedrops 20% — Each patient received three 8-week treatments in a randomized sequence, being PFAT, AS 20% and AS 100%. After 8 weeks of treatment, the treatment effect was evaluated during a scheduled study visit. The patient was then instructed to start a new washout of 2 weeks to immediately follow with the next treatment.
- DRUG: Autologous serum eyedrops 100% — Each patient received three 8-week treatments in a randomized sequence, being PFAT, AS 20% and AS 100%. After 8 weeks of treatment, the treatment effect was evaluated during a scheduled study visit. The patient was then instructed to start a new washout of 2 weeks to immediately follow with the next treatment.
Primary Outcomes
- Change from baseline in participant-reported severity and/or frequency of dry eye-related symptoms based on a validated patient symptom questionnaire (Ocular Surface Disease Index questionnaire, OSDI) (8 weeks)
Secondary Outcomes
- Change from baseline in ocular staining with fluorescein and lissamine green according to the Sjögren's International Collaborative Clinical Alliance Ocular Staining Score (SICCA OSS) (8 weeks)
- Change from baseline in Schirmer 1 tear production test (mm) (8 weeks)
- Change from baseline in best-corrected visual acuity (BCVA, Snellen) (8 weeks)
- Change from baseline in tear film break-up time at the slit lamp (tBUT, sec) (8 weeks)
- Change from baseline in non-invasive break-up-time (NiBUT) using anterior segment ocular coherence tomography (OCT) (sec) (8 weeks)
Full Eligibility Criteria
Inclusion Criteria: The inclusion criteria for patients participating in this study are defined as follows: patients with severe Dry Eye Disease, including severe symptoms as evaluated with a standardized instrument (OSDI score \> 33), associated with at least one of the following objective parameters: A. Tear break-up time (tBUT) as a measure of tear film quality \< 5 seconds B. Positive corneal and conjunctival staining quantified according to the SICCA OSS scale C. Schirmer 1 test score \< 5 mm/5 min (without anesthesia) Exclusion Criteria: The exclusion criteria for patients participating in this study are defined as follows: A. Inability to complete the study protocol, including study-specific procedures. B. Inability to understand the Dutch-language ICF and/or unwillingness or inability to provide signed informed consent. C. History of non-compliance with the proposed therapy D. Presence of known severe anemia based on medical history E. Hypersensitivity to the proposed treatment F. Pregnancy G. Age \<18 years H. In the opinion of the investigator, the subject is not suitable for participation in the study
Trial Locations
- Ghent University Hospital, Ghent, Oost-Vlaanderen, Belgium
Frequently Asked Questions
What is clinical trial NCT07469865?
NCT07469865 is a Not Applicable INTERVENTIONAL study titled "Efficacy and Safety of 20% and 100% Autologous Serum Eye Drops in Patients With Severe Dry Eye Disease (AST)." It is currently completed and is sponsored by University Hospital, Ghent. The trial targets enrollment of 46 participants.
What conditions does NCT07469865 study?
This trial investigates treatments for Dry Eye Disease. The primary condition under study is Dry Eye Disease.
What treatments are being tested in NCT07469865?
The interventions being studied include: Preservative-free artificial tears (DRUG), Autologous serum eyedrops 20% (DRUG), Autologous serum eyedrops 100% (DRUG). Each patient received three 8-week treatments in a randomized sequence, being PFAT, AS 20% and AS 100%. After 8 weeks of treatment, the treatment effect was evaluated during a scheduled study visit. The patient was then instructed to start a new washout of 2 weeks to immediately follow with the next treatment.
What does Not Applicable mean for NCT07469865?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07469865?
This trial is currently "Completed." It started on 2021-11-30. The estimated completion date is 2025-12-30.
Who is sponsoring NCT07469865?
NCT07469865 is sponsored by University Hospital, Ghent. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07469865?
The trial aims to enroll 46 participants. The trial status is completed.
How is NCT07469865 designed?
This is a interventional study, uses randomized allocation, follows a crossover design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT07469865?
The primary outcome measures are: Change from baseline in participant-reported severity and/or frequency of dry eye-related symptoms based on a validated patient symptom questionnaire (Ocular Surface Disease Index questionnaire, OSDI) (8 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07469865 being conducted?
This trial is being conducted at 1 site, including Ghent, Oost-Vlaanderen (Belgium).
Where can I find official information about NCT07469865?
The official record for NCT07469865 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07469865. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07469865 testing in simple terms?
This study tested if eye drops made from a patient's own blood serum (at 20% and 100% concentration) are effective and safe for treating severe dry eye disease. It is for adults (18+) with severe dry eye symptoms that haven't responded well to other treatments and show specific signs of eye surface damage.
Why is this trial significant?
This trial addresses a gap in treatment for severe dry eye by investigating the potential of autologous serum eye drops, which may offer a more natural and personalized approach for patients who don't
What are the potential risks of participating in NCT07469865?
The most common risks are related to eye irritation, stinging, or burning when applying the drops. There's a small risk of infection, as with any eye procedure, and potential for allergic reactions. Some patients might experience temporary blurred vision after applying the drops. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07469865?
Ask your doctor about the specific benefits and risks of using your own serum for eye drops, and how it compares to other treatments. Be prepared for regular visits to the hospital for assessments and to receive the different treatments. The study involves applying different types of eye drops for 8 weeks at a time, with short breaks in between, and undergoing various eye tests. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07469865 signal from an investment perspective?
This study explores a personalized treatment for a common and often debilitating condition, potentially offering a new therapeutic option in the dry eye market, though its commercial viability depends This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants received three different treatments over 8 weeks each: preservative-free artificial tears, 20% serum drops, and 100% serum drops, with a 2-week break between each treatment. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.