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Sponsors and Collaborators: |
Trier Research Laboratories Generalkonsul Einar Høyvalds Fond Jørgen Bagenkop Nielsens Myopi-Fond Chr. Andersen og hustru Ingeborg Andersen, f. Schmidts legat (fond) oprettet af deres datter, frk. Lilli Ellen Andersen. |
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Information provided by: | Trier Research Laboratories |
ClinicalTrials.gov Identifier: | NCT00263471 |
7-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.
Condition | Intervention | Phase |
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Myopia |
Drug: 7-methylxanthine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 2 Study of the Effect of 7-Methylxanthine on the Progression of Childhood Myopia |
Estimated Enrollment: | 90 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | March 2006 |
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.
Ages Eligible for Study: | 8 Years to 13 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Children in the age 8-13 years with myopia and an axial growth rate of 0.15 mm or more per year.
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Exclusion Criteria:
Severe general ailment (for example diabetes, epilepsy, psychiatric disease) Eye diseases (for example cataract, keratoconus, chronic iritis, glaucoma)
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Study Chair: | Klaus Trier, MD | Trier Research Laboratories |
Study ID Numbers: | 2612-2320 |
Study First Received: | December 6, 2005 |
Last Updated: | December 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00263471 |
Health Authority: | Denmark: Danish Medicines Agency |
Eye Diseases Disease Progression Myopia Refractive Errors |