Title
Myopia Progression and the Effect of 7-Methylxanthine
Phase 2 Study of the Effect of 7-Methylxanthine on the Progression of Childhood Myopia
Phase
Phase 2Lead Sponsor
Trier Research LaboratoriesStudy Type
InterventionalStatus
Unknown statusIndication/Condition
MyopiaIntervention/Treatment
7-methylxanthine ...Study Participants
907-methylxanthine has been shown to increase the concentration and thickness of collagen fibrils in rabbit sclera. Deficient collagen in the sclera may be the cause of progression of childhood myopia. The study hypothesis is that treatment with 7-methylxanthine will stabilize the sclera and prevent further progression of myopia.
Participants are given tablets of 7-methylxanthine 400 mg per day or placebo tablets for 12 months. Axial length, cycloplegic refraction and corneal curvature is measured, as well as weight, height, blood pressure and heart rate. The participants are interviewed about possible CNS, gastrointestinal, or cardiopulmonal side effects.
Inclusion Criteria: Children in the age 8-13 years with myopia and an axial growth rate of 0.15 mm or more per year. - Exclusion Criteria: Severe general ailment (for example diabetes, epilepsy, psychiatric disease) Eye diseases (for example cataract, keratoconus, chronic iritis, glaucoma) -