WHO ICTRP trial
A large scale study to confirm and expand the information on the safety and…
EUCTR2020-003976-42-SK · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2020-003976-42-SK |
|---|---|
| Public title | A large scale study to confirm and expand the information on the safety and effectiveness of atropine in treating the progression of myopia in pediatric subjects. |
| Scientific title | A phase III, randomized, double-masked, placebo controlled, parallel-group, multicenter study of the safety and efficacy of OT-101 (Atropine Sulfate 0.01%) in treating the progression of myopia in pediatric subjects |
| Primary sponsor | Ocumension (Hong Kong) Limited |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Netherlands;Hungary;United States;China;Ireland;Poland;United Kingdom;Slovakia;Spain |
| Conditions | myopia MedDRA version: 20.0 Level: PT Classification code 10028651 Term: Myopia System Organ Class: 10015919 - Eye disorders MedDRA version: 20.0 Level: PT Classification code 10069153 Term: Congenital myopia System Organ Class: 10010331… |
| Interventions | Product Name: Atropine sulfate Product Code: OT_101 Pharmaceutical Form: Eye drops, powder and solvent for solution INN or Proposed INN: ATROPINE SULFATE CAS Number: 55-48-1 Current Sponsor code: OT-101 Concentration unit: % percent… |
| Registration date | Oct 12, 2021 |
| Target size | 678 |
| Secondary IDs | OT-101-001;2020-003976-42-NL |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: