Autologous Serum Tears With Hyaluronate vs Balanced Salt Solution for Moderate-to-Severe Dry Eye
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate), Biological - Autologous Serum Tears (50% Autologous Serum Tears + Balanced Saline Solution (BSS), Standard of Care (SOC) Treatment.
- Who it may be relevant to
- Registry conditions: Dry Eye, Eye Diseases, Eyes Dry Chronic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Autologous Serum Tears Diluted to 50% With 0.2% Sodium Hyaluronate-Containing Preservative-Free Artificial Tears Versus Autologous Serum Tears Diluted to 50% With Balanced Salt Solution in Patients With Moderate-to-Severe Dry Eye Disease: A Prospective, Double-Blind, Randomized, Controlled, Contralateral-Eye Study
Overview
This study aims to find out whether adding sodium hyaluronate, a moisturizing ingredient commonly found in artificial tears, makes autologous serum eye drops more effective for treating moderate-to-severe dry eye disease. Each participant will use one version of the drops in one eye and the standard version in the other eye. The goal is to see if the new combination provides better relief, comfort, and eye surface healing compared to the traditional formulation.
Interventions
- Biological Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate)
Autologous serum tears prepared from the participant's own blood, diluted to 50% with 0.2% sodium hyaluronate preservative-free artificial tears, and administered to the randomized study eye. - Biological Biological - Autologous Serum Tears (50% Autologous Serum Tears + Balanced Saline Solution (BSS)
Autologous serum tears prepared from the participant's own blood, diluted to 50% with Balanced Saline Solution, and administered to the contralateral randomized study eye. - Other Standard of Care (SOC) Treatment
Participants will continue their standard-of-care treatment for dry eye disease as outlined in the protocol. SOC may vary per clinician judgment
Primary outcome measures
- OSDI (Ocular Surface Disease Index) Symptom Score (0-100) [Time frame: Baseline, Approximately 12 weeks]
- OSDI (Ocular Surface Disease Index)-6 Symptom Score (0-12) [Time frame: Baseline, Approximately 12 weeks]
- Tear production (mm of wetting in 5 Minutes) [Time frame: Baseline, week 4,week 8,week 12]
- Tear Break Up Time (Seconds) [Time frame: Baseline, week 4,week 8,week 12]
- Corneal Fluorescein Staining (National Eye Institute Score (NEI) 0-15) [Time frame: Baseline, week 4,week 8,week 12]
- Conjunctival Lissamine Green Staining (NEI Score 0-18) [Time frame: Baseline, week 4,week 8,week 12]
- In Vivo Confocal Microscopy Parameters (Quantitative Cellular and Nerve Metrics) [Time frame: Baseline, week 4,week 8,week 12]
- Keratograph 5M Measurement: Non-Invasive Keratographic Break-Up Time (Seconds) [Time frame: Baseline, week 4, week 8, week 12]
- Keratograph 5M Tear Meniscus Height (mm) [Time frame: Baseline, week 4, week 8, week 12]
- Keratograph 5M Measurement: Meibography Grade [Time frame: Baseline, week 4, week 8, week 12]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years old
- Formal diagnosis of one of the following conditions associated with aqueous-deficient dry eye disease: Sjögren's syndrome (primary or secondary), Mucous membrane pemphigoid, Graft-versus-host disease, Stevens-Johnson syndrome, Post-radiation lacrimal gland aqueous deficiency, or Neurotrophic keratitis
- Moderate-to-severe Dry Eye Disease (DED) symptoms for at least 6 months prior to study enrollment.
- OSDI score ≥ 25 and/or and OSDI-6 score > 6 at the screening visit
- Presence of at least two of the following clinical signs in the same eye, at the screening visit: Anesthetized Schirmer's test score 7 ≤ mm at 5 minutes, Tear Break up Time (TBUT) ≤ 7 seconds, Corneal fluorescein staining score ≥ 4 (maximum 15) as assessed by the National Eye Institute (NEI) grading scale 25, or Conjunctival lissamine green staining ≥ 3 (maximum 18) as assessed by the NEI grading scale
- Desire to use autologous serum tears at least twice daily in the 2 weeks prior to screening visit.
Exclusion criteria
- Age <18 years old.
- Cognitive impairment or psychiatric condition that precludes informed consent or the ability to comply with study procedures.
- Any clinical condition identified at screening that, in the opinion of the treating physician, is clinically significant and would contraindicate safe participation in the study.
- Any condition or treatment known to affect the signs and symptoms of DED, including pregnancy, regular use of contact lenses, recent diagnosis of ocular allergy, infection, or inflammation, or recent ocular surgery within 6 months.
- Patients with stable ocular surface disease or neurotrophic keratitis secondary to prior ocular surgery, chronic glaucoma therapy, or eyelid abnormalities may be included.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Bascom Palmer Eye Institute — Miami
Identifiers
NCT: NCT07413172 · 20251145