Dry EyePhase 2NCT07413172
Autologous Serum Tears With Hyaluronate vs Balanced Salt Solution for Moderate-to-Severe Dry Eye
A Phase 2 study testing Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate) and Biological - Autologous Serum Tears (50% Autologous Serum Tears + Balanced Saline Solution (BSS) in people with Dry Eye and Eye Diseases, run by University of Miami at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Eye Diseases, Eyes Dry Chronic
- What is being tested?
- Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate) and Biological - Autologous Serum Tears (50% Autologous Serum Tears + Balanced Saline Solution (BSS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2026to Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Bascom Palmer Eye Institute
Miami, Florida, 33136
Konstantinos Christodoulou, (561) 560-1657, kxc1149@miami.edu
Sotiria Palioura, MD
About this study
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
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.
- Conditions
- Dry Eye, Eye Diseases, Eyes Dry Chronic
- Being tested
- 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
- Medical subject headings
- Dry Eye Syndromes, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate)Biological
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 - Autologous Serum Tears (50% Autologous Serum Tears + Balanced Saline Solution (BSS)Biological
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.
Standard of Care (SOC) TreatmentOther
Participants will continue their standard-of-care treatment for dry eye disease as outlined in the protocol. SOC may vary per clinician judgment
| Study group | Role | What they receive |
|---|---|---|
| Autologous Serum Tears + Sodium Hyaluronate (Eye A) | Experimental | All participants will continue their standard-of-care treatment throughout the study. One eye of each participant will receive autologous serum tears diluted to 50% with 0.2% sodium hyaluronate preservative-free artificial tears 4 times daily for 3 months. Receives: Biological: Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate); Other: Standard of Care (SOC) Treatment |
| Autologous Serum Tears + Balanced Saline Solution (Eye B) | Active comparator | All participants will continue their standard-of-care treatment throughout the study. The fellow eye of each participant will receive autologous serum tears diluted to 50% with Balanced Saline Solution 4 times daily for 3 months. Receives: Biological: Biological - Autologous Serum Tears (50% Autologous Serum Tears + Balanced Saline Solution (BSS); Other: Standard of Care (SOC) Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI (Ocular Surface Disease Index) Symptom Score (0-100)
Change in dry eye symptom severity measured using the Ocular Surface Disease Index (OSDI) questionnaire, scored from 0 to 100, with higher scores indicating greater symptom severity.
Measured: Baseline, Approximately 12 weeks
OSDI (Ocular Surface Disease Index)-6 Symptom Score (0-12)
Change in dry eye symptom severity measured using the Ocular Surface Disease Index (OSDI-6)questionnaire, scored from 0 to 12, with higher scores indicating greater symptom severity.
Measured: Baseline, Approximately 12 weeks
Tear production (mm of wetting in 5 Minutes)
Tear production measured using anesthetized Schirmer's test, reported as millimeters of strip wetting over 5 minutes.
Measured: Baseline, week 4,week 8,week 12
Tear Break Up Time (Seconds)
Mean fluorescein Tear Break Up Time Using slit-lamp and fluorescein dye to review cornea and determine how long it takes for dry spots to occur. Calculated as the average of three measurements and reported in seconds
Measured: Baseline, week 4,week 8,week 12
Corneal Fluorescein Staining (National Eye Institute Score (NEI) 0-15)
Corneal staining severity graded using the NEI scale (0-15), with higher scores indicating more extensive staining
Measured: Baseline, week 4,week 8,week 12
Conjunctival Lissamine Green Staining (NEI Score 0-18)
Conjunctival staining severity graded using the NEI scale (0-18), with higher scores indicating more extensive staining.
Measured: Baseline, week 4,week 8,week 12
In Vivo Confocal Microscopy Parameters (Quantitative Cellular and Nerve Metrics)
Quantitative assessment of corneal cellular structures and sub-basal nerve plexus morphology using in vivo confocal microscopy. Measured in mm/mm².
Measured: Baseline, week 4,week 8,week 12
Keratograph 5M Measurement: Non-Invasive Keratographic Break-Up Time (Seconds)
Non-invasive keratographic break-up time (NIKBUT) will be measured using the Keratograph 5M ocular surface imaging system. Participants will blink normally and then keep their eyes open while the device records the time in seconds until tear film break-up occurs. Higher values indicate greater tear film stability.
Measured: Baseline, week 4, week 8, week 12
Keratograph 5M Tear Meniscus Height (mm)
Tear meniscus height (TMH) will be measured using the Keratograph 5M non-invasive ocular surface imaging system. The Keratograph 5M software will automatically detect and calculate tear meniscus height in millimeters.
Measured: Baseline, week 4, week 8, week 12
Keratograph 5M Measurement: Meibography Grade
Meibography will be performed using the Keratograph 5M non-contact infrared imaging system to assess meibomian gland structure in the upper and lower eyelids. Meibography grading of meibomian gland dropout using a unitless 0-6 meiboscore scale.
Measured: Baseline, week 4, week 8, week 12
Visual Acuity (logMAR Units)
Uncorrected and best-corrected Visual Acuity measured using a standardized logMAR chart and reported in logMAR units
Measured: Baseline, week 4, week 8, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start21 Jul 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sotiria Palioura, University of Miami
- Investigators
- Sotiria Palioura, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413172
- Sponsor's protocol ID
- 20251145
- Status last verified
- Jul 2026
- First submitted
- 9 Feb 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07413172
- Acronym / sponsor ID
- 20251145
- Conditions
- Dry Eye, Eye Diseases, Eyes Dry Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 17 Feb 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Serum Tears + Sodium Hyaluronate (Eye A) | Experimental | Biological: Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate), Other: Standard of Care (SOC) TreatmentAll participants will continue their standard-of-care treatment throughout the study. One eye of each participant will receive autologous serum tears diluted to 50% with 0.2% sodium hyaluronate preservative-free artificial tears 4 times daily for 3 months. |
| Autologous Serum Tears + Balanced Saline Solution (Eye B) | Active comparator | Biological: Biological - Autologous Serum Tears (50% Autologous Serum Tears + Balanced Saline Solution (BSS), Other: Standard of Care (SOC) TreatmentAll participants will continue their standard-of-care treatment throughout the study. The fellow eye of each participant will receive autologous serum tears diluted to 50% with Balanced Saline Solution 4 times daily for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old
Key exclusion criteria (5 listed)
- Age <18 years old.
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 |
|---|---|---|
| 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 | Autologous Serum Tears + Sodium Hyaluronate (Eye A) |
| 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. | Biological | Autologous Serum Tears + Balanced Saline Solution (Eye B) |
| Standard of Care (SOC) TreatmentParticipants will continue their standard-of-care treatment for dry eye disease as outlined in the protocol. SOC may vary per clinician judgment | Other | Autologous Serum Tears + Balanced Saline Solution (Eye B), Autologous Serum Tears + Sodium Hyaluronate (Eye A) |
Primary outcome
OSDI (Ocular Surface Disease Index) Symptom Score (0-100)
Time frame: Baseline, Approximately 12 weeks
Change in dry eye symptom severity measured using the Ocular Surface Disease Index (OSDI) questionnaire, scored from 0 to 100, with higher scores indicating greater symptom severity.
OSDI (Ocular Surface Disease Index)-6 Symptom Score (0-12)
Time frame: Baseline, Approximately 12 weeks
Change in dry eye symptom severity measured using the Ocular Surface Disease Index (OSDI-6)questionnaire, scored from 0 to 12, with higher scores indicating greater symptom severity.
Tear production (mm of wetting in 5 Minutes)
Time frame: Baseline, week 4,week 8,week 12
Tear production measured using anesthetized Schirmer's test, reported as millimeters of strip wetting over 5 minutes.
Tear Break Up Time (Seconds)
Time frame: Baseline, week 4,week 8,week 12
Mean fluorescein Tear Break Up Time Using slit-lamp and fluorescein dye to review cornea and determine how long it takes for dry spots to occur. Calculated as the average of three measurements and reported in seconds
Corneal Fluorescein Staining (National Eye Institute Score (NEI) 0-15)
Time frame: Baseline, week 4,week 8,week 12
Corneal staining severity graded using the NEI scale (0-15), with higher scores indicating more extensive staining
Conjunctival Lissamine Green Staining (NEI Score 0-18)
Time frame: Baseline, week 4,week 8,week 12
Conjunctival staining severity graded using the NEI scale (0-18), with higher scores indicating more extensive staining.
In Vivo Confocal Microscopy Parameters (Quantitative Cellular and Nerve Metrics)
Time frame: Baseline, week 4,week 8,week 12
Quantitative assessment of corneal cellular structures and sub-basal nerve plexus morphology using in vivo confocal microscopy. Measured in mm/mm².
Keratograph 5M Measurement: Non-Invasive Keratographic Break-Up Time (Seconds)
Time frame: Baseline, week 4, week 8, week 12
Non-invasive keratographic break-up time (NIKBUT) will be measured using the Keratograph 5M ocular surface imaging system. Participants will blink normally and then keep their eyes open while the device records the time in seconds until tear film break-up occurs. Higher values indicate greater tear film stability.
Keratograph 5M Tear Meniscus Height (mm)
Time frame: Baseline, week 4, week 8, week 12
Tear meniscus height (TMH) will be measured using the Keratograph 5M non-invasive ocular surface imaging system. The Keratograph 5M software will automatically detect and calculate tear meniscus height in millimeters.
Keratograph 5M Measurement: Meibography Grade
Time frame: Baseline, week 4, week 8, week 12
Meibography will be performed using the Keratograph 5M non-contact infrared imaging system to assess meibomian gland structure in the upper and lower eyelids. Meibography grading of meibomian gland dropout using a unitless 0-6 meiboscore scale.
Visual Acuity (logMAR Units)
Time frame: Baseline, week 4, week 8, week 12
Uncorrected and best-corrected Visual Acuity measured using a standardized logMAR chart and reported in logMAR units
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Sotiria Palioura, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate) and Biological - Autologous Serum Tears (50% Autologous Serum Tears + Balanced Saline Solution (BSS) in people with Dry Eye and Eye Diseases, run by University of Miami at 1 site in United States.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Konstantinos Christodoulou ((561) 560-1657, kxc1149@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSDI (Ocular Surface Disease Index) Symptom Score (0-100) (time frame: Baseline, Approximately 12 weeks). The study lists 11 primary outcomes in all. 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 24 Jul 2026; AzTrials last refreshed its copy on 2 Nov 2026.