A phase III, randomized, double-masked, placebo controlled, parallel-group, multicenter study of the
Research type
Research Study
Full 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
IRAS ID
1003777
Contact name
Dong Hong Chen
Contact email
Sponsor organisation
Ocumension (Hong Kong) Limited
Eudract number
2020-003976-42
Clinicaltrials.gov Identifier
Research summary
This Phase III study. The duration of the study is 4 years. randomised, double-masked trial, this means that
participants will be assigned to the treatment or placebo by random allocation, like tossing a cointo prevent bias in the
study. double-masked trial means that neither the participant, the parent/guardian nor the Optometrist will know
which treatment group your child is in.
The study will evaluate the efficacy OT-101 Ophthalmic Solution in preventing the progression of myopia in children
following 4 years compared to placebo, and also the safety (any side effects) and tolerability (how well tolerated the
treatment is).
The study will be for four years, after 3 years the children will be re-randomised to placebo and OT-101 (to check if
going on placebo after 3 years on OT-101 their myopia progresses). This will be double masked so no one will know
which group they are in.
Each eligible participant will visit the study centre for a total of 11 visits over 4 years. At each visit, assessments which
are detailed below will be performed, the visits will last around 5 hours.
• Medical and medication history.
• Urine pregnancy test (for females of child- bearing potential)
• Adverse events query – at each visit a member of the study team will ask question about the child’s health
• vision-oriented quality of life questionnaire
• Best-corrected distance visual acuity
• Near visual acuity and accommodative amplitude
• Specular microscopy – this assesses the cells in the eye
• Slit lamp bio-microscopy – to examine the back of eye
• Pupil diameter/phototropic pupil size
• Intraocular pressure (IOP)
• Cycloplaegic autorefraction the eye lenses are bending the light
• Examine the fundus part of the eye
To reduce the number of visit to 11 some of the remaining visits (9) will be made by telephone call these are to general
health to check that everything is going well.REC name
HSC REC A
REC reference
21/NI/0085
Date of REC Opinion
29 Jul 2021
REC opinion
Further Information Favourable Opinion