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Sodium Hyaluronate

Sodium Hyaluronate is being studied in clinical trials for different patient groups, including people with eye prosthesis discomfort and patients with knee osteoarthritis. These trials look at how well it works, how safe it is in study settings, and which symptoms or outcomes improve over time.

Table of contents

Trial overview

The source data includes three Phase 3 interventional trials that investigate Sodium Hyaluronate in different clinical settings.[1][2][3]

Two trials studied people with chronic mucopurulent discharge and/or discomfort of the ocular prosthesis socket, and one trial studied patients with knee osteoarthritis.[1][2][3]

All three studies were designed to compare patient outcomes after treatment, rather than to describe the substance itself.[1][2][3]

Eye prosthesis studies

The two eye prosthesis trials had the same title and studied people with chronic discharge and discomfort in the socket of an artificial eye.[1][2]

These studies compared Hylan eye drops, which are listed in the trial data as the Sodium Hyaluronate-related active control, with other treatments such as vitamin A ointment and low-dose steroid eye drops.[1][2]

One of these trials was completed and included 40 participants, while the other was withdrawn and planned to include 100 participants.[1][2]

The brief summary says the study aimed to test the effect of artificial tears, vitamin A ointment, and steroid drops in artificial eye wearers with chronic irritation and/or excess discharge.[1][2]

Knee osteoarthritis study

The third trial is a Phase 3 multicentre, randomized, open clinical trial in patients with knee osteoarthritis.[3]

This study compared allogenic mesenchymal cells, autologous mesenchymal cells, and an active control with hyaluronic acid, which is the term used in the trial data for the control treatment linked to Sodium Hyaluronate research.[3]

The study was authorised and planned to enroll 120 patients.[3]

The goal was to compare clinical, functional, and radiological response, meaning how patients feel, how they function, and what imaging tests show.[3]

What the trials measure

The main outcome in the eye prosthesis studies was the change in discomfort score and discharge score from baseline after 2 weeks of treatment.[1][2]

These scores are simple study measurements used to track whether symptoms get better or worse over time.[1][2]

In the knee osteoarthritis study, the main outcomes were pain intensity on the VAS pain scale, functional capacity and pain on the Lequesne scale, symptom burden and physical disability on the WOMAC scale, and lesion improvement or stabilization on T2-mapping MR images at 12 months.[3]

T2-mapping MR images are a type of MRI scan used in the study to look at tissue changes inside the knee joint.[3]

Study status and size

The trial statuses in the data were completed, withdrawn, and authorised.[1][2][3]

The planned or reported enrollment ranged from 40 to 120 participants, showing that these were relatively small to moderate Phase 3 studies.[1][2][3]

Across the source data, the trials focused on symptom relief, function, and imaging outcomes in clearly defined patient groups.[1][2][3]

Trial ID Phase Condition studied Status Enrollment
2023-504451-27-01 Phase 3 Chronic mucopurulent discharge and/or discomfort of the ocular prosthesis socket Completed 40
2023-504451-27-00 Phase 3 Chronic mucopurulent discharge and/or discomfort of the ocular prosthesis socket Withdrawn 100
NCT05086939 Phase 3 Knee osteoarthritis Authorised 120

FAQ

  • What conditions are being studied in trials of Sodium Hyaluronate? The trial data shows two main conditions: chronic discharge and discomfort in the eye prosthesis socket, and knee osteoarthritis. These studies focus on different patient groups and different ways of using the treatment.
  • Who can take part in these trials? One trial includes people who wear an artificial eye and have ongoing irritation or discharge. Another trial includes patients with knee osteoarthritis.
  • What phase are the Sodium Hyaluronate trials? The trials in the source data are Phase 3 studies. Phase 3 means the treatment is being tested in larger groups to compare outcomes in real patient settings.
  • What are the trials trying to measure? The eye trial measures changes in discomfort and discharge after 2 weeks. The knee trial measures pain, function, disability, and imaging changes over 12 months.
  • Are all the trials still active? No. One eye trial was completed, one was withdrawn, and the knee osteoarthritis trial is authorised. The status helps show where each study is in the research process.

Ongoing Clinical Trials on Sodium Hyaluronate

  • Study Comparing Allogeneic and Autologous Mesenchymal Stem Cells with Hyaluronic Acid for Patients with Knee Osteoarthritis

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Spain

Glossary

  • Clinical trial: A research study in people that tests a treatment or compares treatments to see what works best.
  • Phase 3: A later stage of testing in larger groups of patients. It helps compare how well a treatment works and how outcomes differ between groups.
  • Interventional study: A study where researchers give a treatment or compare treatments and then measure the results.
  • Enrollment: The number of people planned or included in a study.
  • Primary outcome: The main result the researchers want to measure, such as pain, discomfort, or discharge.
  • Baseline: The starting point before treatment begins. Results are often compared against this point.
  • Ocular prosthesis socket: The space that holds an artificial eye.
  • Mucopurulent discharge: Thick discharge that contains mucus and pus.
  • Knee osteoarthritis: A joint condition where the knee becomes painful and stiff because the joint is worn down.
  • VAS pain scale: A pain rating scale used in studies to measure how strong pain feels.
  • Lequesne scale: A questionnaire or score used to measure pain and how well a person can function with joint disease.
  • WOMAC scale: A score used to measure pain, stiffness, and physical difficulty in people with osteoarthritis.

References