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Study on the Effectiveness and Safety of Hydrocortisone Sodium Phosphate for Patients with Dry Eye and Moderate Meibomian Gland Dysfunction

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for Dry Eye Disease associated with moderate Meibomian Gland Dysfunction. The treatment being tested includes the use of eye drops containing hydrocortisone sodium phosphate, which is a type of medication that helps reduce inflammation. The study will also involve the use of lid hygiene practices, artificial tears, and a medical device called the BlephaEyeBag, which is a reusable eye bag that can be heated in a microwave.

The purpose of the study is to evaluate the effectiveness and safety of this treatment combination. Participants will be monitored over a period of time to observe changes in their symptoms and any potential side effects. The study will track changes in symptoms from the start of the study to two weeks later, and will also look at the levels of certain proteins in tears that are related to inflammation. Additionally, the study will monitor the pressure inside the eyes at various points to ensure safety.

Participants will be asked to follow the treatment plan and attend several follow-up visits over a few months. During these visits, researchers will assess the symptoms of dry eye and meibomian gland dysfunction, as well as any changes in vision or eye health. The study aims to provide valuable information on how well this treatment works and its safety for people with these eye conditions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as age and diagnosis of dry eye disease and meibomian gland dysfunction.

    You will receive detailed information about the study objectives and procedures. You will be asked to sign an informed consent form to confirm your participation.

  2. Step 2

    Baseline assessment

    A baseline assessment will be conducted to evaluate your current symptoms and eye condition. This includes measuring the time it takes for your tears to break up, known as the tear break-up time (TBUT), and assessing your ocular surface disease index (OSDI) score.

    Your intraocular pressure (IOP) will also be measured to ensure it is within a normal range.

  3. Step 3

    Treatment phase

    You will begin the treatment phase, which involves using Softacort 3.35 mg/ml eye drops. These drops contain hydrocortisone sodium phosphate and are used to treat dry eye symptoms.

    The eye drops are to be administered as directed by the study team, typically for a duration of 14 days. You will also use lid hygiene practices, artificial tears, and a medical device called BlephaEyeBag®.

  4. Step 4

    Follow-up visits

    You will attend follow-up visits on Day 14, Day 28, and Day 84. During these visits, your symptoms and eye condition will be reassessed.

    The study team will measure changes in your symptom scores, inflammatory markers in your tears, and intraocular pressure to monitor the treatment's efficacy and safety.

  5. Step 5

    Final assessment

    At the end of the study period, a final assessment will be conducted to evaluate the overall changes in your eye condition and symptoms.

    The study team will review all collected data to determine the treatment's effectiveness and any potential side effects experienced during the trial.

Who can join the trial?

7 criteria

  • Age must be 18 years or older.
  • Must have a documented diagnosis of Dry Eye (DE), which is defined by a TBUT value of 5 seconds or less. TBUT stands for Tear Break-Up Time, a test that measures how quickly tears evaporate from the eye.
  • Must have normal eye health findings, except for dry eye disease and Meibomian Gland Dysfunction (MGD). MGD is a condition affecting the glands in the eyelids that help keep the eyes moist.
  • Must have an OSDI score greater than 23, indicating moderate symptoms. OSDI stands for Ocular Surface Disease Index, a questionnaire that measures the severity of dry eye symptoms.
  • Must have a documented diagnosis of MGD grade 2 to 3. This refers to the severity of the Meibomian Gland Dysfunction.
  • Must be able to understand the instructions and follow the medication regimen.
  • Must receive complete information about the study objectives, agree to participate, and sign an Informed Consent Form (ICF) before joining the study.

Who cannot join the trial?

8 criteria

  • Patients who have any other eye conditions that could interfere with the study.
  • Patients who have had eye surgery in the last 6 months.
  • Patients who are currently using any other eye treatments that are not part of the study.
  • Patients who have a known allergy to any of the study treatments, including **hydrocortisone** (a type of steroid medication).
  • Patients who have a history of increased **intraocular pressure** (pressure inside the eye) or **glaucoma** (a condition that can cause vision loss).
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have any serious health conditions that could affect their participation in the study.
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Investigated drugs

  • Hydrocortisone

    is a medication used in this trial to help reduce inflammation and relieve symptoms of dry eye disease. It is applied topically, meaning it is used directly on the surface of the eye. In this study, hydrocortisone is being tested to see if it can improve the symptoms of dry eye disease when used alongside other treatments.

  • Artificial Tears

    are eye drops that help to lubricate the eyes, providing relief from dryness and irritation. They are used in this trial to help manage the symptoms of dry eye disease by keeping the eyes moist and comfortable.

  • BlephaEyeBag®

    is a medical device used in this trial to help treat dry eye disease. It is designed to be used on the eyelids to provide warmth and improve the function of the meibomian glands, which are responsible for producing oils that keep the eyes from drying out. This device is used in combination with other treatments to see if it can enhance their effectiveness in relieving dry eye symptoms.

What is already known about the treatment

Hydrocortisone – Hydrocortisone is administered topically, meaning it is applied directly to the skin or affected area, in this case, the eyes. It is currently being studied for its effectiveness and safety in treating dry eye disease associated with moderate meibomian gland dysfunction. The main therapeutic use of hydrocortisone in this context is to reduce inflammation and improve symptoms of dry eye. At the molecular level, hydrocortisone works by decreasing the production of substances in the body that cause inflammation. It is classified as a corticosteroid, which is a type of medication that mimics the effects of hormones your body naturally produces in the adrenal glands.

Investigated diseases

  • Dry Eye

    Dry Eye is a condition where the eyes do not produce enough tears or the tears evaporate too quickly, leading to dryness and discomfort. It often results in a gritty or burning sensation in the eyes, redness, and blurred vision. The condition can progress to cause inflammation and damage to the surface of the eye if not managed. Environmental factors like wind or smoke can exacerbate symptoms. Over time, the lack of adequate lubrication can lead to increased sensitivity to light and difficulty wearing contact lenses.

  • Meibomian Gland Dysfunction

    Meibomian Gland Dysfunction (MGD) is a condition affecting the meibomian glands in the eyelids, which are responsible for secreting oils that prevent tear evaporation. In MGD, these glands become blocked or produce poor-quality oil, leading to dry eye symptoms. The condition can cause irritation, redness, and a sensation of having a foreign body in the eye. As MGD progresses, it can lead to inflammation of the eyelids and contribute to chronic dry eye. The dysfunction may also result in changes to the tear film, causing visual disturbances.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518093-13-00Protocol codeTHEA_HLF_1/21Estimated enrolment54 patientsSponsorLaboratorios Thea S.A.

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