Ongoing Clinical Trials for Myopia
This article provides detailed information about 9 ongoing clinical trials investigating treatments for myopia in children and adolescents. The trials are taking place across Europe and focus primarily on atropine eye drops in various concentrations, as well as combination therapies with special lenses. These studies aim to slow down the progression of nearsightedness in young patients.
Clinical trial locations
- Austria
- Czechia
- Germany
- Hungary
- Italy
- Netherlands
- Poland
- Slovakia
- Spain
- United Kingdom
Study of atropine eye drops (0.
This trial examines the effectiveness of atropine eye drops in two different strengths (0.025% and 0.05%) compared to placebo in preventing the worsening of nearsightedness in children and teenagers aged 3 to 18 years.
Inclusion criteria: Participants must be between 3 and 17 years old and have nearsightedness of at least -0.75 diopters in both eyes. Eye pressure must be 21 mm Hg or lower. Parents or legal guardians must sign an informed consent form. For female participants who have started menstruation and male participants who are sexually active, effective birth control is required.
Exclusion criteria: The trial excludes children who have allergic reactions to atropine or similar medications, previous or current eye conditions other than nearsightedness (such as glaucoma or lazy eye), active eye infections, previous eye surgery or trauma, inability to discontinue contact lens use, current participation in other clinical trials, medical conditions that could affect eye examination results, known heart problems, severe neurological or psychiatric conditions, and pregnancy or planning pregnancy.
Trial focus: The study involves using atropine eye drops daily for 24 months. Participants will receive two drops per day throughout the treatment period. Regular check-ups will be scheduled at 3, 6, 12, 18, and 24 months to monitor changes in eye prescription, eye length, vision quality for both near and far sight, pupil size, and the eye’s ability to focus. Participants will also complete questionnaires about the eye drops and their impact on daily life.
Investigational drug: Atropine is an eye drop medication that temporarily affects the focusing ability of the eye and may help control how the eye grows during childhood. This medication has been used for many years in eye care and is being studied to reduce the worsening of nearsightedness in young people.
Comparison of Atropine 0.
This clinical trial compares two different concentrations of atropine eye drops (0.5% and 0.05%) to determine which works better in European children who have progressive nearsightedness.
Inclusion criteria: Children must be between 6 and 11 years old and have nearsightedness in both eyes that started when they were 4 years or older. There must be evidence that the nearsightedness has been getting worse over time. The vision prescription must be between -1.00 and -6.00 diopters in each eye when measured during an eye exam with dilated pupils. The pressure inside each eye must be less than 21 millimeters of mercury.
Exclusion criteria: The trial excludes children who do not have progressive nearsightedness, those outside the age group of 6-11 years, children with known allergies to atropine or similar medications, those currently using other eye medications, children with other significant eye conditions besides nearsightedness, those who have participated in another clinical trial within the past 30 days, children who cannot follow the study protocol or attend regular follow-up visits, those with a history of serious eye injuries or surgeries, children with medical conditions that could affect vision development, and those who cannot properly use eye drops.
Trial focus: Participants will need to apply the eye drops to both eyes daily. The treatment will continue for an extended period to monitor the progression of nearsightedness. Regular check-ups will measure changes in eye length and vision prescription. After the treatment period ends, eyes will be monitored to check for any changes in progression. The study will conclude by January 31, 2031.
Investigational drug: Atropine eye drops work by relaxing the muscles in the eye that control focusing. The eye drops help prevent the eye from lengthening, which is what causes increasing nearsightedness. Atropine has been used in eye care for many years and is considered a standard treatment for preventing worsening of nearsightedness in children.
Study on Brimonidine Eye Drops to Prevent Myopia Progression in Children Aged 6 to 14 Years
This study assesses the effect of brimonidine eye drops 0.025% on the progression of nearsightedness in children over a two-year period.
Inclusion criteria: Children must be between 6 and 14 years old. Both the patient (if over 12 years old) and their legal representative must give written consent. Participants must have nearsightedness of at least -1.50 diopters but not more than -5.50 diopters, astigmatism not exceeding -1.50 diopters, and the difference in prescription between both eyes must not exceed 1.25 diopters. Visual acuity must be better than 0.3 logMAR, and intraocular pressure must be less than 20 mm Hg. Women who can become pregnant must have a negative pregnancy test, and both women and men who can have children must agree to use effective birth control until 6 months after the last treatment.
Exclusion criteria: The trial excludes children younger than 6 years or older than 14 years, those with a history of wearing bifocal or multifocal glasses, those who have used atropine eye drops for nearsightedness in the past, children with a history of contact lens use, those with abnormal eye development or eye diseases other than nearsightedness, children with a history of eye surgery, those with known allergies to brimonidine or its components, children with heart or blood vessel diseases, kidney or liver problems, certain brain disorders, and those taking medications that could interact with brimonidine or participating in other clinical trials.
Trial focus: Participants will use brimonidine eye drops as prescribed. Follow-up visits will occur every 6 months during the 2-year study period. At each visit, progression will be measured, including changes in refractive error, the axial length of the eye, visual acuity for both distance and near vision, and intraocular pressure. After 2 years of treatment, a final comprehensive eye examination will be conducted to evaluate the effectiveness of the brimonidine eye drops.
Investigational drug: Brimonidine is a medication that comes in the form of eye drops. It works by affecting certain receptors in the eye, which may influence how the eye grows and develops. Brimonidine belongs to the class of drugs called alpha-2 adrenergic agonists, which are already established treatments for glaucoma. A lower concentration (0.025%) is being studied specifically for its potential to control progression in children aged 6-14 years.
Study of Atropine Sulfate eye drops (0.
This study evaluates a new eye drop solution called OT-101 containing atropine sulfate at a concentration of 0.01% to determine how well these eye drops work in slowing down the progression of nearsightedness in children over a three-year treatment period.
Inclusion criteria: Parent or legal guardian must provide written informed consent. Participants must be between 3-15 years at the first visit and have nearsightedness between -1.00 and -6.00 diopters with astigmatism no more than 1.50 diopters. The difference in vision between eyes must not exceed 1.0 diopters. Participants must meet minimum vision requirements based on age. Female participants who can bear children must have a negative pregnancy test, not be breastfeeding, and use acceptable birth control throughout the study.
Exclusion criteria: The trial excludes children below 6 years or above 12 years at enrollment, those with a history of eye diseases other than nearsightedness, previous eye surgery or laser treatment, current use of contact lenses or other vision correction treatments, allergies to eye medications, active eye infections or inflammation, participation in other clinical trials within the past 30 days, medical conditions that could affect vision, inability to follow study instructions, known sensitivity to study medication components, history of poor compliance with medical treatments, systemic diseases that could impact eye health, and inability of parent/guardian to provide informed consent.
Trial focus: The treatment will continue for 36 months (3 years). Participants will be randomly assigned to receive either Atropine Sulfate 0.01% eye drops or placebo eye drops. Regular check-ups will be scheduled to monitor eye condition, and eye measurements will be taken using specialized equipment to track changes in vision. After 36 months, the final eye examination will measure the change in the eye’s focusing power and the length of the eye.
Investigational drug: OT-101 (Atropine) is an eye drop solution used to slow down the progression of nearsightedness in children. It works by affecting the way the eye grows and develops during childhood. The medication is applied directly to the eyes and helps prevent the eye from becoming more nearsighted over time. A placebo is also used as a comparison and contains no active ingredients.
Study on Atropine Sulfate Eye Drops to Slow Down Myopia in European Children
This clinical trial aims to find the best dose of atropine sulfate eye drops to slow down the worsening of nearsightedness in European children. The study tests different low doses: 0.05%, 0.025%, 0.01%, and 0.005%, along with a placebo.
Inclusion criteria: Children must be boys or girls aged between 6 and 12 years old. Girls who have started their menstrual cycle must use a very effective method to prevent pregnancy. Children must have nearsightedness with a measurement between -1.0 and -4.0 diopters in at least one eye, with noticeable worsening in the past year. Parents or legal guardians must be informed about the study and sign a consent form.
Exclusion criteria: Children with any eye diseases other than nearsightedness, those who have had eye surgery in the past, children currently using other eye medications, those with allergies to atropine or any of its ingredients, children with any serious health conditions that might affect the study, and those not able to follow study instructions cannot participate.
Trial focus: Participants are randomly assigned to receive one of the different doses of atropine sulfate eye drops or a placebo. The study is double-blind, meaning neither participants nor researchers know which treatment is being administered. Eye drops are applied directly to the eyes. Participants undergo regular assessments to monitor changes over a 12-month period, including measuring changes in vision, eye growth, lens thickness, pupil size, and visual acuity. The study is expected to conclude in June 2025.
Investigational drug: Atropine Eye Drops are being studied in low doses to help prevent the eyes from getting worse over time. The study is testing different strengths of atropine to see which one works best for children. Atropine works by blocking certain receptors in the eye, which helps to reduce the elongation of the eyeball that leads to nearsightedness.
Study on Low-Dose Atropine Sulfate Eye Drops for Controlling Progressive Myopia in Caucasian Children
This clinical trial studies progressive nearsightedness using Atropine Sulfate eye drops in two different low doses: 0.02% and 0.01%. The study will last for one year to determine if the 0.02% dose is more effective than a placebo in slowing down the worsening of nearsightedness in children of Caucasian origin.
Inclusion criteria: Children must be between 8 to 12 years old and have progressive nearsightedness with a level of nearsightedness between -1 D to -6 D. There must be a history of worsening by at least 0.5 D per year. Both the child and their parents or legal guardians must give written informed consent. The child must be able to understand the trial and follow the instructions.
Exclusion criteria: Patients with any eye condition other than progressive nearsightedness, those who have had any eye surgery in the past, patients currently using any medication that affects the eyes other than the study medication, those with a known allergy to atropine, patients with any serious health condition that might interfere with the study, and those unable to follow study procedures or attend required visits cannot participate.
Trial focus: Participants will be provided with Atropine Sulfate 0.02% eye drops for use once daily in each eye. The duration of this treatment is one year. Regular follow-up visits will be scheduled to monitor progress, during which eye prescription and eye length will be measured to assess any changes. At the end of the one-year treatment period, a final assessment will measure the change in eye prescription and eye length.
Investigational drug: Atropine is a medication used in this trial to help control nearsightedness in children. Atropine eye drops work by relaxing certain muscles in the eye, which can help slow down the progression. The focus is on using a low-dose version of atropine to see if it is more effective than a placebo in controlling nearsightedness in children over a year.
Study on the Effectiveness and Safety of Atropine and DIMS Lenses for Myopia Control in Children
This clinical trial investigates the effectiveness and safety of a treatment that combines diluted atropine sulfate eye drops with special lenses called DIMS lenses to help manage nearsightedness in children.
Inclusion criteria: Patients must be between 4 and 16 years old, have nearsightedness greater than -1.00 dioptres, and show a worsening of nearsightedness by at least -0.50 D in the last 12 months. Patients can have astigmatism of 2 D or less and anisometropia of 1.50 D or less. Best-corrected monocular visual acuity must be 0.2 logMAR or better. Parents or guardians must sign an informed consent form for all patients, and patients aged 12-16 years must also agree to participate. Children under 12 need to give their assent.
Exclusion criteria: Patients who have any other eye conditions besides nearsightedness, those who have had eye surgery in the past, patients currently using other treatments for nearsightedness, those with allergies to any of the study medications or materials, patients with any serious health conditions that might affect the study results, and those unable to follow study procedures or attend all required visits are excluded.
Trial focus: An initial eye examination is conducted to measure refractive error, axial length, and visual acuity. Participants receive diluted atropine eye drops at a concentration of 0.025% applied ophthalmically. DIMS technology lenses are also used to help control progression. Regular follow-up visits are scheduled to monitor changes in refractive error, axial length, and intraocular pressure. Optical Coherence Tomography is used to measure changes in choroidal and retinal thickness. The study is estimated to conclude by June 30, 2026.
Investigational drugs: Atropine is an eye drop medication that works by relaxing certain muscles in the eye, which can help slow down the worsening over time. DIMS Lenses are special ophthalmic lenses designed to help manage nearsightedness in children using a technology that helps to reduce the strain on the eyes. They are worn like regular glasses and are part of the treatment being tested.
Study on the Effects of Atropine Sulfate Monohydrate Eye Drops in Slowing Myopia Progression in Children
This clinical trial tests eye drops containing atropine sulfate monohydrate in two different concentrations, Atropini collyrium 0.02% and Atropini collyrium 0.04%, compared to a placebo to see how well they work in slowing down the progression of nearsightedness in children.
Inclusion criteria: Children must be aged 6 to 12 years old and have been diagnosed with nearsightedness with a specific range of vision measurements: -0.5 to -4.75 for the spherical component and 0 to -2.5 for astigmatism in at least one eye. Vision in the worse eye should be better or equal to a specific level measured by logMAR test. Specific measurements from corneal topography should be within certain limits. Both eyes should have normal findings and history except for needing glasses or having had minor eye issues. Both eyes should have normal binocular functions except for exophoria within a certain range. Normal intraocular pressure should be 22 or less in both eyes. There should be a specific amount of growth in the length of the eye over a certain period before joining. The child and their parents or legal guardian must be willing to apply eye drops daily for two years, attend clinical exams every six months for three years, and keep a weekly diary.
Exclusion criteria: Children who are not diagnosed with nearsightedness, those outside the specified age range, children with any other eye conditions that might affect study results, those who have had previous eye surgeries, children currently using other eye medications, those with allergies to the study medication or similar substances, children with any serious health conditions that might interfere, and those unable to attend all required study visits cannot participate.
Trial focus: Patients will be randomly assigned to one of three groups receiving different eye drops: Atropini collyrium 0.04%, Atropini collyrium 0.02%, or a placebo collyrium. The study is double-blinded. Patients will apply the assigned eye drops daily for 24 months. Clinical examinations will occur every six months to assess various aspects of eye health, including axial eye length, visual acuity, and other growth characteristics. Patients will maintain a weekly diary recording the daily application and any side effects. The study is expected to conclude by December 31, 2025.
Investigational drug: Atropine Collyrium is an eye drop solution used to slow down the progression of nearsightedness in children. The study aims to evaluate the effectiveness, safety, and side effects of this medication. Atropine works by relaxing certain muscles in the eye, which may help in reducing the rate at which nearsightedness worsens.
Study on the Safety and Effectiveness of SYD-101 Eye Drops with Atropine Sulfate Monohydrate for Treating Myopia in Children
This clinical trial tests a treatment called SYD-101, which is an eye drop solution containing the active ingredient atropine sulfate monohydrate. The purpose is to evaluate how effective SYD-101 is in slowing down the progression of nearsightedness in children, as well as to assess its safety and tolerability.
Inclusion criteria: The child’s parent or guardian must understand and sign an informed consent form before any study-related activities. The child must also agree to participate if old enough to understand. The child must have a vision test result of 75 letters or better and normal eye pressure (less than 21 mmHg). The child must be between 3 and 14 years old at the first screening. Both the child and their parent or guardian must be willing and able to follow study instructions, attend study visits, and complete study procedures. The child or their parent/guardian must be able to use artificial eye drops during initial visits. The child must be in good overall health. If the child is a girl who has started menstruating, she must have a negative pregnancy test. The child’s eye prescription must have nearsightedness between 0.50 and 6.00 diopters, astigmatism of 1.50 diopters or less, and anisometropia of 1.00 diopter or less. If nearsightedness is less than 0.75 diopters, there must be a history of worsening by 0.50 diopters in the last 6 to 12 months.
Exclusion criteria: Children who do not have nearsightedness, those not within the specified age range, children with other eye conditions that might interfere, those taking medications that could affect vision, children who have had eye surgery recently, those with allergies to the study medication, and children unable to follow study procedures are excluded.
Trial focus: Participants will be randomly assigned to receive either the SYD-101 eye drops or a control solution without the active drug. The study is double-masked, meaning neither the participant nor the study team will know which solution is being administered. The participant will use the assigned eye drops as directed for up to 48 months. Regular follow-up visits will monitor the progression 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. The primary goal is to evaluate the mean annual progression rate over 24 months. The study is expected to conclude by May 31, 2025.
Investigational drug: SYD-101 is an ophthalmic solution being studied for its potential to slow down the progression of nearsightedness in children. 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 development. It is classified pharmacologically as an ophthalmic agent, specifically designed for eye-related conditions.
Summary
The 9 ongoing clinical trials for myopia treatment are distributed across 10 European countries, with Spain hosting the highest number of trials (4), followed by Poland and Slovakia (2 each). Most trials focus on low-dose atropine eye drops in various concentrations ranging from 0.005% to 0.5%, reflecting the current research interest in this established medication for myopia control in children.
All trials target pediatric populations, typically children aged 3 to 16 years, emphasizing the importance of early intervention in managing progressive nearsightedness. The majority of studies use atropine sulfate monohydrate as the primary investigational drug, with treatment durations ranging from 12 months to 48 months. One notable trial investigates brimonidine as an alternative medication, and another examines a combination therapy using atropine with special DIMS lenses.
Common exclusion criteria across trials include previous eye surgery, allergies to study medications, other eye conditions beyond nearsightedness, and inability to comply with study protocols. Most trials require informed consent from parents or legal guardians and, where appropriate, assent from the children themselves.
