Braking effect on myopia with atropine eye drops at 0.01%.

Phase 1

• Conditions: Myopia; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2019-002535-28-FR
• Lead Sponsor: Hôpitaux Universitaires de Strasbourg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-30
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: A
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

-- Children with myopia between -1 and -6 spherical diopters measured under cycloplegia with an automatic refractor.
- Progressive myopia characterized by a minimal rate of progression of -0.75 diopters in the last 12 months
- Age between 4 and 12 years old included at the time of signing the consent.
- Negative urinary pregnancy test for women of childbearing age using an effective contraceptive method (oral, intravaginal or transdermal estroprogestogenic hormonal contraception or oral, subcutaneous, injectable or intrauterine device, or intrauterine hormonal device, occlusion sterilization of the fallopian tubes, sexual abstinence)
- Consent to participate in the study signed by both parents of the child.
- Subject affiliated to a social security health insurance scheme.

Are the trial subjects under 18? yes
Number of subjects for this age range: 160
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Astigmatism = with 1.5 diopters
- Anisometropy = with 2 diopters
- Presence of an ocular surface or corneal pathology (recurrent keratalgia, keratoconus)
- Presence of a pathology of the anterior segment (Iranian malformation, cataract)
- Presence of a pathology of the posterior or retinal segment (dystrophies or acquired diseases)
- Presence of an old or progressive inflammatory pathology (uveitis)
- Presence of strabismus or disturbance of stereoscopic vision (Lang Test not seen)
- Presence of amblyopia
- Contraindication to the use of the investigational medicinal product and/or to the explorations provided for in the protocol
- Hypersensitivity to atropine or any of the excipients of the eye drops present in the raw material
- Impossibility of giving the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.)
- Subjects treated with psychotropic drugs
- Subjects with a psychiatric condition
- Subject under the protection of justice
- Subject under guardianship or curatorship
- Pregnant and breastfeeding women
-Women capable of procreation (from first menstruation to menopause) not using contraceptive methods. In the event of a first menstruation occurring during the subject's participation, a urinary pregnancy test will be performed and an effective method of contraception will be initiated (oral, intravaginal or transdermal estroprogestogenic hormonal contraception or oral, subcutaneous, injectable or progestin-only hormonal contraception or intrauterine device, or intrauterine hormonal device, fallopian tube occlusion sterilization, sexual abstinence)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified