---
title: Autologous Serum Tears With Hyaluronate vs Balanced Salt Solution for Moderate-to-Severe Dry Eye
nct_id: NCT07413172
overall_status: NOT_YET_RECRUITING
phase: PHASE2
sponsor: University of Miami
study_type: INTERVENTIONAL
primary_condition: Dry Eye
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07413172.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07413172"
ct_last_update_post_date: 2026-04-17
last_seen_at: "2026-05-12T07:13:02.884Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Autologous Serum Tears With Hyaluronate vs Balanced Salt Solution for Moderate-to-Severe Dry Eye

**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

**NCT ID:** [NCT07413172](https://clinicaltrials.gov/study/NCT07413172)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** University of Miami
- **Conditions:** Dry Eye, Eye Diseases, Eyes Dry Chronic
- **Start Date:** 2026-07
- **Completion Date:** 2028-07
- **CT.gov Last Update:** 2026-04-17

## Brief 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. 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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.
- **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.

## Interventions

- **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) Treatment** (OTHER) — Participants will continue their standard-of-care treatment for dry eye disease as outlined in the protocol. SOC may vary per clinician judgment

## Primary Outcomes

- **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

## Locations (1)

- Bascom Palmer Eye Institute, Miami, Florida, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.bascom palmer eye institute|miami|florida|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT07413172*  
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