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NCT07413172 · ClinicalTrials.gov registry record · Phase 2
Autologous Serum Tears With Hyaluronate vs Balanced Salt Solution for Moderate-to-Severe Dry Eye
A Phase 2 study, sponsored by University of Miami.
- Not yet
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT07413172: Clinical Trial Phase 2 study, sponsored by University of Miami.
NCT07413172 is a Phase 2 study that has not yet begun recruiting, run by University of Miami. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07413172, a Phase 2 study, has not yet begun recruiting, sponsored by University of Miami.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- BIOLOGICAL Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate)
- BIOLOGICAL Biological - Autologous Serum Tears (50% Autologous Serum Tears + Balanced Saline Solution (BSS)
- OTHER Standard of Care (SOC) Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-07 |
| Est. Completion | 2028-07 |
| Phase | Phase 2 |
What is known before NCT07413172 opens enrollment
NCT07413172 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate) is the first listed.
NCT07413172 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07413172 about?
NCT07413172 is a clinical study titled "Autologous Serum Tears With Hyaluronate vs Balanced Salt Solution for Moderate-to-Severe Dry Eye". 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...
What is the current status of trial NCT07413172?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2026-07. Estimated completion is 2028-07.
What interventions are being tested in trial NCT07413172?
The interventions under investigation include: Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate) (BIOLOGICAL), Biological - Autologous Serum Tears (50% Autologous Serum Tears + Balanced Saline Solution (BSS) (BIOLOGICAL), Standard of Care (SOC) Treatment (OTHER).
Who is sponsoring clinical trial NCT07413172?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07413172's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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