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Study Comparing Laser Treatment and Tafluprost Eye Drops for Patients with Exfoliation Glaucoma or Ocular Hypertension

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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 two eye conditions: glaucoma and ocular hypertension. These conditions involve increased pressure in the eye, which can lead to vision problems if not treated. The study is comparing two treatments for these conditions: a laser procedure called Selective Laser Trabeculoplasty (SLT) and eye drops. The eye drops being tested contain a medication called tafluprost, which is used to lower eye pressure.

The purpose of the study is to determine if the SLT laser treatment is as effective as the eye drops when used as the first treatment option for a specific type of glaucoma known as exfoliation glaucoma. Participants in the study will be randomly assigned to receive either the laser treatment or the eye drops. The study will monitor the effectiveness of these treatments over a period of time, looking at factors such as the need to add more eye drops, eye dryness, and changes in eye pressure.

The study will also assess the long-term success of the SLT treatment and whether there is a need for further glaucoma surgery. Participants will be followed for a period to observe these outcomes. The goal is to provide valuable information on the best initial treatment approach for managing exfoliation glaucoma and ocular hypertension.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the trial, an initial assessment is conducted to confirm eligibility. This includes verifying age between 50 and 100 years, the ability to participate for 12 months, and a diagnosis of exfoliation glaucoma or ocular hypertension with eye pressure less than 35 mmHg.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving selective laser trabeculoplasty (SLT) and the other receiving eye drops as the first line of treatment.

  3. Step 3

    Treatment administration

    For those in the eye drops group, the medication used is tafluprost, administered as eye drops. The dosage is 15 micrograms per milliliter, applied once daily in the evening.

    Participants in the SLT group undergo a laser procedure aimed at reducing eye pressure.

  4. Step 4

    Follow-up visits

    Regular follow-up visits are scheduled to monitor eye pressure, assess for any side effects such as eye dryness, and evaluate the overall success of the treatment.

  5. Step 5

    Evaluation of treatment efficacy

    The primary goal is to determine if the SLT laser treatment is as effective as the eye drops in managing exfoliation glaucoma.

    Secondary evaluations include monitoring for eye dryness, changes in eye pressure, and the long-term success of SLT treatment, as well as the potential need for glaucoma surgery.

  6. Step 6

    Completion of trial

    The trial is expected to continue until December 1, 2030. Participants will be monitored throughout the trial period to gather comprehensive data on the effectiveness and safety of the treatments.

Who can join the trial?

6 criteria

  • Provide informed consent, which means you agree to participate after understanding the study details.
  • Be between the ages of 50 and 100 years.
  • Be able to attend the study for a period of 12 months.
  • Have a condition called exfoliation, which is related to the eye.
  • Have been newly diagnosed with exfoliation glaucoma or have ocular hypertension (high eye pressure) of 24 mmHg or more, according to the European Glaucoma Society guidelines.
  • Have an eye pressure that is less than 35 mmHg.

Who cannot join the trial?

7 criteria

  • Patients who have any other eye condition besides glaucoma that might affect the study results.
  • Patients who have had previous eye surgery that could interfere with the study.
  • Patients who are currently using medications that might affect the study results.
  • Patients who have a history of severe allergic reactions to medications used in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have participated in another clinical trial within the last 30 days.
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Investigated drugs

  • Selective Laser Trabeculoplasty (SLT)

    is a type of laser treatment used to lower pressure in the eye. It is often used for patients with glaucoma or high eye pressure. The laser helps to improve the drainage of fluid from the eye, which can reduce the pressure and help prevent damage to the optic nerve.

  • Eye Drops

    are medications used to lower eye pressure in patients with glaucoma or ocular hypertension. These drops work by either reducing the amount of fluid produced in the eye or by helping the fluid drain out of the eye more effectively. They are often used as a first-line treatment to manage eye pressure and prevent vision loss.

What is already known about the treatment

Eye Drops for Glaucoma – This medication is administered in the form of eye drops, applied directly to the eyes. It is currently used in medical practice for managing glaucoma, a condition characterized by increased pressure in the eye. The main therapeutic indication is to lower intraocular pressure to prevent damage to the optic nerve. The medication works by either decreasing the production of fluid within the eye or increasing its outflow, thereby reducing pressure. It is classified pharmacologically as an antiglaucoma agent.

Investigated diseases

Glaucoma – Glaucoma is a group of eye conditions that damage the optic nerve, which is crucial for good vision. This damage is often caused by abnormally high pressure in the eye. Over time, increased pressure can erode the optic nerve tissue, which may lead to vision loss or even blindness if not managed. The progression of glaucoma is typically slow, and it may not show symptoms until significant damage has occurred. It is most commonly seen in older adults, but it can occur at any age. Regular eye exams are important to detect the condition early and prevent further damage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520083-33-00Estimated enrolment112 patientsSponsorHUS-yhtymae

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).