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Myopia Progression and the Effect of 7-Methylxanthine

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ClinicalTrials.gov Identifier: NCT00263471
Recruitment Status : Unknown
Verified October 2003 by Trier Research Laboratories.
Recruitment status was:  Active, not recruiting
First Posted : December 8, 2005
Last Update Posted : December 14, 2005
Sponsor:
Collaborators:
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.
Information provided by:
Trier Research Laboratories

Brief Summary:
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 or disease Intervention/treatment Phase
Myopia Drug: 7-methylxanthine Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Phase 2 Study of the Effect of 7-Methylxanthine on the Progression of Childhood Myopia
Study Start Date : October 2003
Study Completion Date : March 2006



Primary Outcome Measures :
  1. Axial growth

Secondary Outcome Measures :
  1. Myopia progression


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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263471


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.
Investigators
Study Chair: Klaus Trier, MD Trier Research Laboratories