In short
Clinical trials are studying Atropine Sulfate mainly for myopia control in children and other eye research settings. These studies look at safety, effectiveness, and the best dose or treatment plan. Most trials focus on pediatric patients with progressive myopia.
Key points
- Clinical trials of Atropine Sulfate are mainly focused on slowing myopia in children and adolescents. The studies include Phase 2, Phase 3, and Phase 1/2 trials, with most being interventional and many using placebo comparisons. Researchers are testing different low-dose eye drop strengths and, in one study, a combined approach with DIMS lenses. The main outcomes include changes in myopia measured by eye testing, and in some studies, changes in axial length. Most participants are pediatric patients with progressive myopia, while one study involves patients with retinitis pigmentosa. Several trials are authorised, and one dose-finding study has been completed.
Clinical trial overview
These trials study Atropine Sulfate mainly for myopia, which means nearsightedness.
Most studies ask whether Atropine Sulfate can slow myopia progression, meaning the worsening of nearsightedness over time.
The trial data show that the main target population is children, especially pediatric patients with progressive myopia.
Study designs and phases
The studies are interventional, which means the researchers give a treatment and then measure the results.
Several trials are randomized and double-blind, so assignment to groups is by chance and the study is designed to reduce bias.
Placebo-controlled studies are also used, meaning one group gets eye drops without the active study drug so the treatment effect can be compared fairly.
The trial phases include Phase 2, Phase 3, and Phase 1/2.
Phase 2 studies usually help find the best dose, while Phase 3 studies compare how well the treatment works and how safe it is in larger groups.
Who can participate
Most trials focus on children with myopia or progressive myopia.
One study specifically mentions pediatric subjects, and another study focuses on European children with progressive myopia.
One trial in the data is different: it includes patients with retinitis pigmentosa, a separate eye condition, and Atropine Sulfate appears as one of several listed eye treatments in that study record.
What the trials measure
The main outcomes focus on change in myopia over time, usually measured by cycloplegic refraction or spherical equivalent.
Cycloplegic refraction means an eye test done after drops that relax focusing, so the measurement is more accurate for nearsightedness.
Some studies also measure axial length, which is the front-to-back length of the eye and is important in myopia research.
Safety is also measured in some trials, including adverse events, eye examinations, inflammation checks, vital signs, and laboratory tests.
Key trial details
NCT04770610 is a Phase 3, randomized, double-masked, placebo-controlled, multicenter study in pediatric subjects with myopia.
It studies Atropine Sulfate 0.01% ophthalmic solution and aims to evaluate whether treatment can reduce the progression of myopia over 3 years.
The primary outcome is the percentage of study eyes with progressive myopia at Month 36, measured by cycloplegic autorefraction.
2024-516758-23-00 is a Phase 2 dose-finding study in children with myopia progression in a European population.
It compares 0.05%, 0.025%, 0.01%, and 0.005% Atropine Sulfate eye drops with placebo to find the best low-dose option.
The main endpoint is the change in myopia over the first 12 months, measured by spherical equivalent with cycloplegia.
NCT03865160 is a Phase 3 study of low-dose Atropine Sulfate eye drops in children with progressive myopia.
It compares 0.02% and 0.01% eye drops with placebo in children of Caucasian origin.
The primary outcome is change in cycloplegic refraction per year after 1 year of treatment.
NCT05667454 is a Phase 3 study in European children with progressive myopia.
It compares Atropine 0.05% with Atropine 0.5% and also looks at safety, adherence, and reasons for nonresponse.
The primary outcome is to compare the effect on axial length progression, which helps show whether the eye is getting longer as myopia worsens.
NCT06431841 is a Phase 3 postmarketing trial in a pediatric population with myopia.
It studies diluted atropine eye drops 0.025% together with DIMS technology ophthalmic lenses, which are special lenses used in myopia control.
The primary outcomes are change in refractive error after cycloplegia and the proportion of patients with adverse events.
Other eye research that includes Atropine Sulfate
2024-511687-90-00 is a Phase 1/2 study in patients with retinitis pigmentosa and mutations in the PDE6B gene.
This study is mainly about the safety of a unilateral subretinal administration of HORA-PDE6B, and Atropine Sulfate is listed among several eye-related treatments in the record.
The primary endpoints are safety checks such as ophthalmic examination, inflammation, chorioretinal tolerance, questionnaires, vital signs, and laboratory measurements.