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Study on the Safety and Effectiveness of SYD-101 Eye Drops with Atropine Sulfate Monohydrate for Treating Myopia in Children

Verified siteInvestigationalNo 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 condition known as myopia, which is commonly referred to as nearsightedness. This condition affects the ability to see distant objects clearly. The study is testing a treatment called SYD-101, which is an eye drop solution containing the active ingredient atropine sulfate monohydrate. The purpose of the study is to evaluate how effective SYD-101 is in slowing down the progression of myopia in children, as well as to assess its safety and how well it is tolerated by the participants.

Participants in the study will be randomly assigned to receive either the SYD-101 eye drops or a similar solution that does not contain the active drug, known as a placebo. The study is designed to be "double-masked," meaning that neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not influenced by expectations. The treatment period will last for up to 48 months, during which participants will use the eye drops daily.

Throughout the study, participants will have regular check-ups to monitor the progression of their myopia and to check for any side effects. The main goal is to see if the use of SYD-101 can reduce the rate at which myopia worsens over time. The study will also gather information on any changes in vision and overall eye health. This research aims to provide valuable insights into managing myopia in children and potentially improving their quality of life by preserving their vision.

The research process

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

Step 1
Joining the study
Upon joining the study, the participant will be randomly assigned to receive either the SYD-101 eye drops or a control solution that does not contain the active drug.
The study is designed to be double-masked, meaning neither the participant nor the study team will know which solution is being administered.
Step 2
Administration of eye drops
The participant will use the assigned eye drops as directed. The drops are administered as a solution for the eyes.
The frequency and dosage of the eye drops will be specified by the study protocol and must be followed precisely.
Step 3
Regular follow-up visits
The participant will attend regular follow-up visits to monitor the progression of myopia and assess the safety and tolerability of the treatment.
These visits will include various assessments such as visual acuity tests, eye pressure measurements, and other relevant examinations.
Step 4
Evaluation of myopia progression
The primary goal is to evaluate the mean annual progression rate of myopia over a period of 24 months.
Secondary evaluations will include the proportion of participants with specific rates of myopia progression and changes in eye measurements.
Step 5
Completion of the study
The study is expected to conclude by May 31, 2025.
Upon completion, the data collected will be analyzed to determine the efficacy and safety of SYD-101 in slowing the progression of myopia in children.

Who can join the trial?

13 criteria

The child's parent or guardian must understand and agree to sign a form that explains the study before any study-related activities begin. The child must also agree to participate if they are old enough to understand.
The child must have a vision test result of 75 letters or better, which is similar to seeing 20/32 on a standard eye chart.
The child must have normal eye pressure, which is less than 21 mmHg.
The child must be between 3 and 14 years old at the time of the first screening.
The child and their parent or guardian must be willing and able to follow the study instructions, attend study visits, and complete study procedures.
The child or their parent/guardian must be able to use artificial eye drops during the initial visits.
The child must be in good overall health, with no significant health issues based on their medical history and vital signs, as determined by the study doctor during the screening.
If the child is a girl who has started menstruating, she must have a negative pregnancy test result.
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The child's eye prescription must meet specific criteria:
- Myopia (nearsightedness) between 0.50 and 6.00 diopters
- Astigmatism (a common vision condition) of 1.50 diopters or less
- Anisometropia (difference in prescription between the two eyes) of 1.00 diopter or less
- If the child's myopia is less than 0.75 diopters, they must have a history of worsening myopia by 0.50 diopters in the last 6 to 12 months.
- If the child's myopia is 0.75 diopters or more, they must be wearing glasses or contact lenses that correct their vision to within specific limits based on the study doctor's measurements.

Who cannot join the trial?

7 criteria

Children who do not have myopia, which is a condition where distant objects appear blurry.
Children who are not within the specified age range for the study.
Children who have other eye conditions that might interfere with the study.
Children who are taking medications that could affect their vision.
Children who have had eye surgery recently.
Children who have allergies to the study medication.
Children who are unable to follow the study procedures.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
Vienna, Austria
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Konvent Der Barmherzigen Brueder
Linz, Austria
Verified
Medical University Of Graz
Graz, Austria

Trial locations

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Investigated drugs

SYD-101 is an ophthalmic solution being studied for its potential to slow down the progression of myopia, which is a condition where distant objects appear blurry, in children. The trial aims to assess how effective and safe this solution is for young patients.

Atropine Sulfate Monohydrate

What is already known about the treatment

SYD-101 – This medication is administered as an ophthalmic solution, meaning it is applied directly to the eyes. Currently, SYD-101 is being studied in clinical trials to determine its safety and effectiveness in treating myopia, particularly in children. The main therapeutic indication for SYD-101 is to slow the progression of myopia, a condition characterized by nearsightedness. At the molecular level, SYD-101 is believed to work by altering the biochemical pathways in the eye that contribute to the elongation of the eyeball, which is a key factor in myopia development. It is classified pharmacologically as an ophthalmic agent, specifically designed for eye-related conditions.

Investigated diseases

Myopia – Myopia, commonly known as nearsightedness, is a vision condition where close objects are seen clearly, but distant objects appear blurry. It occurs when the eyeball is too long or the cornea is too curved, causing light rays to focus in front of the retina instead of on it. This condition often begins in childhood and can progress as the child grows. As myopia progresses, the ability to see distant objects becomes increasingly impaired. The progression rate can vary, with some individuals experiencing rapid changes while others have a more gradual progression. Regular eye examinations are important to monitor changes in vision and adjust corrective lenses as needed.