Publication date context February 19 2026. A University of Miami led clinical trial is advancing the discussion on biologic tear substitutes for moderate to severe dry eye. The study compares two autologous serum tear formulations in combination with either 0.2 percent sodium hyaluronate or balanced saline solution and includes a standard of care arm. Clinicians regulators and researchers should watch for trial progress and eventual results to inform patient selection and product development.
What changed in the dry eye trial landscape?
The public record NCT07413172 indicates a three arm study focusing on autologous serum tears as a core biologic intervention for dry eye. Arm one pairs fifty percent autologous serum tears with 0.2 percent sodium hyaluronate. Arm two pairs fifty percent autologous serum tears with balanced saline solution. Arm three follows standard of care. The sponsor is University of Miami. The trial status is not yet recruiting, signaling that enrollment has not started. These details are published on ClinicalTrials.gov and signal ongoing regulatory interest in tear based biologics and formulation differences in this class of products.
Arms details
Arms details expand on what is compared in this trial. Arm one uses fifty percent autologous serum tears with 0.2 percent sodium hyaluronate. Arm two uses fifty percent autologous serum tears with balanced saline solution. Arm three uses standard of care. The source text does not provide endpoints or results.
How is the trial designed and who sponsors it?
The design as listed includes three arms: two investigational combinations of autologous serum tears with either sodium hyaluronate or balanced saline solution, and a third arm of standard of care. Arm one relies on fifty percent autologous serum tears with 0.2 percent sodium hyaluronate. Arm two relies on fifty percent autologous serum tears with balanced saline solution. Arm three follows standard of care. The sponsor is University of Miami. The status is not yet recruiting which means the study has not begun enrolling participants. The record is posted on ClinicalTrials.gov to enable transparency and public access to protocol information during regulatory review and potential later phases.
Who should care about this trial and why?
Clinicians treating moderate to severe dry eye may benefit if the study shows advantages for these autologous serum tear formulations. Regulators and manufacturers focusing on biologic tear substitutes will monitor the trial design and safety safeguards as the field moves toward later phase work. The University of Miami sponsorship signals an academic research effort that may influence future discussions on data requirements and comparative design in this therapeutic area.
What are the regulatory implications for this trial?
Because this is a registered study on ClinicalTrials.gov the project will be subject to standard registration and protocol transparency obligations. The use of autologous serum tears with adjuncts such as sodium hyaluronate or balanced saline solution involves biologic materials and formulation steps that may require safety and quality oversight. Although no results are yet available the inclusion of a standard of care arm aligns with the need for a clear baseline when future data are reported to regulators and the public.
Arms of the trial
Arms details expand on what is compared in this trial. Arm one uses fifty percent autologous serum tears with 0.2 percent sodium hyaluronate. Arm two uses fifty percent autologous serum tears with balanced saline solution. Arm three uses standard of care. The source text does not provide endpoints or results.
Conclusion and implications
The trial record confirms ongoing interest in autologous serum tears as a treatment option for dry eye. Clinicians and regulators should track the study as it progresses toward enrollment and eventual results that may inform product development and clinical practice.
1. What is being studied? The trial investigates two autologous serum tear formulations in combination with either 0.2 percent sodium hyaluronate or balanced saline solution, plus a standard of care arm.
2. Who funds the study? The sponsor listed is the University of Miami.
3. When will results be available? The trial status is not yet recruiting, so results are not available at this time.
4. Where can I learn more? See the ClinicalTrials.gov record NCT07413172 at https://clinicaltrials.gov/study/NCT07413172?term=medical+device
Professional disclaimer
This information is intended for professionals and does not constitute legal advice. It reflects the source text and publicly available trial records. For regulatory decisions, consult official guidelines and regulatory counsel.
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https://clinicaltrials.gov/study/NCT07413172?term=medical+device