Clinical trial • Phase III • Ophthalmology

ATROPINE SULFATE for Progressive myopia

Phase III trial of ATROPINE SULFATE for Progressive myopia.

Overview

Trial Therapeutic Area
Ophthalmology
Trial Disease
Progressive myopia
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
02-10-2024
First CTIS Authorization Date
24-10-2024

Trial design

Placebo: Eye drops, solution (apart from the active substance identical to the IMP) administered by ophthalmic route; comparator product listed as 'Eye drops, solution. Apart from the active substance identical to the IMP.' (no dosing frequency/schedule specified).-controlled Phase III trial in Germany.

Comparator
Placebo: Eye drops, solution (apart from the active substance identical to the IMP) administered by ophthalmic route; comparator product listed as 'Eye drops, solution. Apart from the active substance identical to the IMP.' (no dosing frequency/schedule specified).
Target Sample Size
300
Trial Duration For Participant
365

Eligibility

Recruits 300 paediatric patients.

Vulnerable Population
Children aged 8-12 years are a vulnerable population for this trial. Written informed consent must be obtained from parents or legal guardians and written informed consent from the patient if applicable; ability to understand trial procedures is required. A specific ICF/SIS for 8-12 year olds is listed in the documents. Parents or children with poor understanding of the German language are excluded.

Inclusion criteria

  • {"criterion_text":"- Male or female patients aged 8 to 12 years (up to the day before the 13th birthday)\n- Myopia of -1 D to -6 D with reported or documented annual progression ≥ 0.5 D of myopia\n- Written informed consent obtained from patient (if applicable) and parents or legal guardians according to international guidelines and local laws\n- Ability to understand the nature of the trial and the trial related procedures and to comply with them"}

Exclusion criteria

  • {"criterion_text":"- Asian or African origin\n- Abnormal binocularity\n- Strabismus\n- Astigmatism >1.5 D\n- Anisometropia >1.5 D\n- History of amblyopia\n- Corrected visual acuity in any eye <0.63\n- Any acquired or developmental organic eye disease\n- Premature birth\n- Any known systemic metabolic disease or chromosomal anomaly\n- Previous use of any kind of contact lenses\n- Previous use of atropine eye drops\n- Epilepsy\n- Known hypersensitivity to the active substances or any of the excipients\n- Participation in any other interventional clinical trial within the last 30 days before the start of this trial\n- Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed\n- Contraindications according to the Summary of Product Characteristics (SmPC): Increased intraocular pressure (primary forms of glaucoma or narrow angle glaucoma), chronic rhinitis sicca\n- Caution and pediatric counselling shall be assured if any of the following conditions are present according to the Summary of Product Characteristics (SmPC): Cardiac insufficiency, arrhythmia, coronary stenosis, hyperthyroidism, stomach or bowel stenosis, bowel paralysis, megacolon, muscle weakness, lung edema, hypersensitivity to atropine, spastic paralysis\n- Parents or children with poor understanding of the German language\n- Person who is in a relationship of dependence/employment with the sponsor or the investigator"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change of cycloplegic refraction/year [D/year] after 1 year of treatment.","definition_or_measurement_approach":"Measured as change of cycloplegic refraction per year [diopter per year (D/year)], assessed after one year of treatment (cycloplegic refraction)."}

Secondary endpoints

  • {"endpoint_text":"- Axial eye length change/year [mm/year] after 1 year.","definition_or_measurement_approach":"Measured as change in axial eye length in millimetres per year [mm/year], assessed after one year of treatment."}
  • {"endpoint_text":"- Categorized rate of change in refraction and eye length after 1 year.","definition_or_measurement_approach":"Categorization of rate of change in refraction and axial eye length after one year (categories defined by degree of change in refraction and/or axial length over 1 year)."}

Recruitment

Planned Sample Size
300
Recruitment Window Months
72
Consent Approach
Written informed consent must be obtained from the parents or legal guardians and from the patient if applicable, in accordance with international guidelines and local laws. Separate subject information and informed consent forms are provided for adults and for 8-12 year olds (documents: 'L1_SIS and ICF Adults' and 'L1_SIS and ICF 8-12 yr'). Parents or children with poor understanding of the German language are excluded (language requirement).

Geography

Total Number Of Sites
16
Total Number Of Participants
300

Germany

Earliest CTIS Part Ii Submission Date
15-07-2024
Latest Decision Or Authorization Date
24-10-2024
Processing Time Days
101
Number Of Sites
16
Number Of Participants
300

Sites

Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Augenheilkunde
Principal Investigator Name
Wolf A. Lagrèze
Principal Investigator Email
wolf.lagreze@uniklinik-freiburg.de
Contact Person Name
Wolf A. Lagrèze
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Orthoptik und Neuroophtalmologie
Principal Investigator Name
Bettina Wabbels
Principal Investigator Email
bettina.wabbels@ukbonn.de
Contact Person Name
Bettina Wabbels
Contact Person Email
bettina.wabbels@ukbonn.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Augenklinik und Poliklinik
Principal Investigator Name
Theresia Ring-Mangold
Principal Investigator Email
theresia.ring@med.uni-muenchen.de
Contact Person Name
Theresia Ring-Mangold
Site Name
Otto Von Guericke Universitaet Magdeburg
Department Name
Klinik für Augenheilkunde
Principal Investigator Name
Claudia Schuart
Principal Investigator Email
claudia.schuart@med.ovgu.de
Contact Person Name
Claudia Schuart
Contact Person Email
claudia.schuart@med.ovgu.de
Site Name
University Hospital Cologne AöR
Department Name
Zentrum für Augenheilkunde
Principal Investigator Name
Andrea Hedergott
Principal Investigator Email
andrea.hedergott@uk-koeln.de
Contact Person Name
Andrea Hedergott
Contact Person Email
andrea.hedergott@uk-koeln.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Zentrum für Augenheilkunde
Principal Investigator Name
Christina Beisse
Principal Investigator Email
Christina.Beisse@med.uni-heidelberg.de
Contact Person Name
Christina Beisse
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Augenheilkunde
Principal Investigator Name
Armin Wolf
Principal Investigator Email
Armin.Wolf@uniklinik-ulm.de
Contact Person Name
Armin Wolf
Contact Person Email
Armin.Wolf@uniklinik-ulm.de
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Augenheilkunde
Principal Investigator Name
Karsten Hufendiek
Principal Investigator Email
hufendiek.karsten@mh-hannover.de
Contact Person Name
Karsten Hufendiek
Site Name
Universitaet Muenster
Department Name
Klinik für Augenheilkunde
Principal Investigator Name
Nicole Eter
Principal Investigator Email
nicole.eter@ukmuenster.de
Contact Person Name
Nicole Eter
Contact Person Email
nicole.eter@ukmuenster.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Augenheilkunde
Principal Investigator Name
Anja Eckstein
Principal Investigator Email
anja.eckstein@uk-essen.de
Contact Person Name
Anja Eckstein
Contact Person Email
anja.eckstein@uk-essen.de
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Augenheilkunde
Principal Investigator Name
Caroline Bormann
Principal Investigator Email
caroline.bormann@medizin.uni-leipzig.de
Contact Person Name
Caroline Bormann
Site Name
Pius-Hospital Oldenburg
Department Name
Universitätsklinik für Augenheilkunde
Principal Investigator Name
Thomas Lischka
Principal Investigator Email
thomas.lischka@pius-hospital.de
Contact Person Name
Thomas Lischka
Site Name
Universitaetsmedizin Goettingen
Department Name
Augenklinik
Principal Investigator Name
Michael Schittkowski
Principal Investigator Email
michael.schittkowski@med.uni-goettingen.de
Contact Person Name
Michael Schittkowski
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Augenklinik
Principal Investigator Name
Gabriele Gusek-Schneider
Principal Investigator Email
gabriele.gusek-schneider@uk-erlangen.de
Contact Person Name
Gabriele Gusek-Schneider
Site Name
Augencentrum
Department Name
Augenklinik
Principal Investigator Name
Philipp Eberwein
Principal Investigator Email
prof.eberwein@augencentrum.de
Contact Person Name
Philipp Eberwein
Contact Person Email
prof.eberwein@augencentrum.de
Site Name
Augen-Zentrum-Nordwest
Department Name
Augenpraxis Ahaus
Principal Investigator Name
Stefanie Schmickler
Principal Investigator Email
St.schmickler@augen-zentrum-nordwest.de
Contact Person Name
Stefanie Schmickler

Sponsor

Primary sponsor

Full Name
Medical Center - University Of Freiburg
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
Atropine Sulfate 0.02% eye drops, solution
Active Substance
ATROPINE SULFATE
Modality
Small molecule
Routes Of Administration
Ophthalmic (eye drops)
Route
Ophthalmic
Authorisation Status
National MIA numbers provided: DE_BW_01_MIA_2020_0101/DE_BW_01_Universitätsapotheke Freiburg
Starting Dose
0.02% (W/V)
Dose Levels
0.02% (W/V)
Maximum Dose
0.02% (W/V)
Investigational Product Name
Atropine Sulfate 0.01% eye drops, solution
Active Substance
ATROPINE SULFATE
Modality
Small molecule
Routes Of Administration
Ophthalmic (eye drops)
Route
Ophthalmic
Authorisation Status
National MIA numbers provided: DE_BW_01_MIA_2020_0101/DE_BW_01_Universitätsapotheke FR; DE_BY_05_MIA_2020_0044/SG55.2-2678.1-8-54-5
Starting Dose
0.01% (W/V)
Dose Levels
0.01% (W/V)
Maximum Dose
0.01% (W/V)
Investigational Product Name
Eye drops, solution. Apart from the active substance identical to the IMP.
Modality
Other
Routes Of Administration
Ophthalmic (eye drops)
Route
Ophthalmic
Authorisation Status
National MIA number provided: DE_BW_01_MIA_2020_0101/DE_BW_01_Universitätsapotheke Freiburg
Starting Dose
0% (placebo)
Dose Levels
Placebo (no active substance)
Maximum Dose
0% (placebo)

Related trials

Other published trials that may interest you.