Study of Atropine Sulfate eye drops (0.

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What is this study about?

This study focuses on treating myopia, also known as nearsightedness, in children. The condition occurs when distant objects appear blurry while close objects remain clear. The research evaluates a new eye drop solution called OT-101 containing atropine sulfate at a concentration of 0.01%.

The purpose of this study is to determine how well these eye drops work in slowing down the progression of myopia in children over a three-year treatment period. The study will compare the effectiveness of OT-101 eye drops against a placebo solution that looks the same but contains no active medication.

During the study, participants will receive either the OT-101 eye drops or placebo drops. The drops will be administered through ophthalmic use (placed directly in the eyes). The treatment will continue for three years, with regular check-ups to monitor changes in vision. The study will measure how the eye drops affect the progression of nearsightedness using specialized eye examinations.

1 Initial screening visit

Your eye doctor will perform an eye examination using cycloplegic autorefraction (a test that measures your eye’s focusing power)

The doctor will check if your vision meets the required criteria: myopia between -1.00 and -6.00, with astigmatism not exceeding 1.50

Your vision will be tested using special eye charts (ETDRS or Lea Chart for children who don’t know the alphabet)

If applicable, a pregnancy test will be performed for female participants of childbearing age

2 Treatment assignment

You will be randomly assigned to receive either Atropine Sulfate 0.01% eye drops or placebo eye drops (drops without active medication)

Neither you nor your doctor will know which type of drops you are receiving

3 Treatment period

The treatment will continue for 36 months (3 years)

You will need to use the assigned eye drops as directed by your doctor

Regular check-ups will be scheduled to monitor your eye condition

Your eye measurements will be taken using specialized equipment to track changes in your vision

4 Final evaluation

After 36 months, your final eye examination will be performed

The doctor will measure the change in your eye’s focusing power using cycloplegic autorefraction

The length of your eye will be measured using cycloplegic biometry

These measurements will help determine if the treatment has helped slow down the progression of myopia (nearsightedness)

Who Can Join the Study?

Parent or legal guardian must provide written informed consent and sign required documentation. Where appropriate, child’s agreement to participate should also be obtained
Must be able to attend all study visits and understand native language. Parent/legal guardian must accompany the participant
Age must be between 3-15 years at the first visit
Must have specific vision conditions:
- Myopia (nearsightedness) between -1.00 and -6.00 diopters
- Astigmatism (irregular eye shape affecting vision) no more than 1.50 diopters
Difference in vision between eyes (anisometropia) must not exceed 1.0 diopters
Must have minimum vision requirements based on age:
- Age 3: vision of 20/50 or better
- Age 4: vision of 20/40 or better
- Age 5 and older: vision of 20/30 or better
Female participants who can bear children must:
- Have a negative pregnancy test at screening
- Not be breastfeeding
- Use acceptable birth control throughout the study
Must be willing to avoid prohibited medications during the study period

Who Cannot Join the Study?

Age below 6 years or above 12 years at the time of enrollment
History of eye diseases other than myopia (such as glaucoma, cataracts, or retinal disorders)
Previous eye surgery or laser treatment
Current use of contact lenses or other vision correction treatments
Allergies to eye medications or eye drops
Active eye infections or inflammation
Participation in other clinical trials within the past 30 days
Medical conditions that could affect vision or study participation
Unable to follow study instructions or attend regular follow-up visits
Known sensitivity to any components of the study medication
History of poor compliance with medical treatments
Systemic diseases (diseases affecting the whole body) that could impact eye health
Inability of parent/guardian to provide informed consent
Any condition that, in the investigator’s opinion, makes the patient unsuitable for the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
3 F s.r.o.	Kosice	Slovakia

Other Sites

Site Name	City	Country
Warszawski Szpital Okulistyczny Sp. z o.o.	Warsaw	Poland
Oftalmologia Vistahermosa S.L.	Burjassot	Spain
University Of Debrecen	Debrecen	Hungary
University Of Pecs	Pecs	Hungary
OptoKid Kft.	Budapest	Hungary
Centro De Oftalmologia Barraquer S.A.	Barcelona	Spain
University Of Szeged	Szeged	Hungary
Budapest Retina Associates	Budapest	Hungary
Crcrkba Mbpqlrsh Dnjsry 1u Sno z oulu	Cracow	Poland
Veryudgrz sbkxjt	Trencin	Slovakia
Onfadnzby slomey	Zilina	Slovakia
Ixbgaepsq Dn Mboswamxljlf Oiundc Dmw Sxnv	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Hungary	Not recruiting	15.12.2021
Ireland	Not recruiting	15.12.2021
Poland	Not recruiting	15.12.2021
Slovakia	Not recruiting	15.12.2021
Spain	Not recruiting	15.12.2021

Trial locations

Investigated drugs:

Atropine Sulfate

OT-101 (Atropine) is an eye drop solution used to slow down the progression of nearsightedness (myopia) 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. This treatment is being studied as a way to help children maintain better vision as they grow older.

Placebo is an inactive substance that looks identical to the real medication but contains no active ingredients. It is used as a comparison to determine if the actual medication is effective.

Investigated diseases:

Myopia

Myopia – A vision condition in which close objects are seen clearly, but objects farther away appear blurred. This occurs when the eye grows too long from front to back, or the cornea has too much curvature, causing light rays to focus in front of the retina instead of directly on it. Myopia typically develops during childhood and adolescence, and may continue to progress until early adulthood. The condition can range from mild to severe, affecting daily activities like reading signs or driving. In children, myopia often worsens as they grow and their eyes continue to develop.

Trial ID:

2024-516315-24-00

Protocol code:

OT-101-001

NCT ID:

NCT04770610

Trial Phase:

Therapeutic confirmatory (Phase III)

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