Table of Contents
- Clinical trial overview
- Study designs and phases
- Who can participate
- What the trials measure
- Key trial details
- Other eye research that includes Atropine Sulfate
Clinical trial overview
These trials study Atropine Sulfate mainly for myopia, which means nearsightedness.[1][2][3][4][5]
Most studies ask whether Atropine Sulfate can slow myopia progression, meaning the worsening of nearsightedness over time.[1][2][3][4][5]
The trial data show that the main target population is children, especially pediatric patients with progressive myopia.[1][2][3][4][5]
Study designs and phases
The studies are interventional, which means the researchers give a treatment and then measure the results.[1][2][3][4][5]
Several trials are randomized and double-blind, so assignment to groups is by chance and the study is designed to reduce bias.[1][2]
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.[1][2][3][5]
The trial phases include Phase 2, Phase 3, and Phase 1/2.[1][2][3][4][5]
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.[2][1][3][4][5]
Who can participate
Most trials focus on children with myopia or progressive myopia.[1][2][3][4]
One study specifically mentions pediatric subjects, and another study focuses on European children with progressive myopia.[1][3][4]
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.[3]
What the trials measure
The main outcomes focus on change in myopia over time, usually measured by cycloplegic refraction or spherical equivalent.[1][2][4][5]
Cycloplegic refraction means an eye test done after drops that relax focusing, so the measurement is more accurate for nearsightedness.[1][2][4]
Some studies also measure axial length, which is the front-to-back length of the eye and is important in myopia research.[4][5]
Safety is also measured in some trials, including adverse events, eye examinations, inflammation checks, vital signs, and laboratory tests.[3][5]
Key trial details
NCT04770610 is a Phase 3, randomized, double-masked, placebo-controlled, multicenter study in pediatric subjects with myopia.[1]
It studies Atropine Sulfate 0.01% ophthalmic solution and aims to evaluate whether treatment can reduce the progression of myopia over 3 years.[1]
The primary outcome is the percentage of study eyes with progressive myopia at Month 36, measured by cycloplegic autorefraction.[1]
2024-516758-23-00 is a Phase 2 dose-finding study in children with myopia progression in a European population.[2]
It compares 0.05%, 0.025%, 0.01%, and 0.005% Atropine Sulfate eye drops with placebo to find the best low-dose option.[2]
The main endpoint is the change in myopia over the first 12 months, measured by spherical equivalent with cycloplegia.[2]
NCT03865160 is a Phase 3 study of low-dose Atropine Sulfate eye drops in children with progressive myopia.[4]
It compares 0.02% and 0.01% eye drops with placebo in children of Caucasian origin.[4]
The primary outcome is change in cycloplegic refraction per year after 1 year of treatment.[4]
NCT05667454 is a Phase 3 study in European children with progressive myopia.[5]
It compares Atropine 0.05% with Atropine 0.5% and also looks at safety, adherence, and reasons for nonresponse.[5]
The primary outcome is to compare the effect on axial length progression, which helps show whether the eye is getting longer as myopia worsens.[5]
NCT06431841 is a Phase 3 postmarketing trial in a pediatric population with myopia.[6]
It studies diluted atropine eye drops 0.025% together with DIMS technology ophthalmic lenses, which are special lenses used in myopia control.[6]
The primary outcomes are change in refractive error after cycloplegia and the proportion of patients with adverse events.[6]
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.[3]
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.[3]
The primary endpoints are safety checks such as ophthalmic examination, inflammation, chorioretinal tolerance, questionnaires, vital signs, and laboratory measurements.[3]
