Myopia Progression and the Effect of 7-Methylxanthine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2003 by Trier Research Laboratories.
Recruitment status was  Active, not recruiting
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
ClinicalTrials.gov Identifier:
NCT00263471
First received: December 6, 2005
Last updated: December 13, 2005
Last verified: October 2003
  Purpose

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
Myopia
Drug: 7-methylxanthine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Phase 2 Study of the Effect of 7-Methylxanthine on the Progression of Childhood Myopia

Further study details as provided by Trier Research Laboratories:

Primary Outcome Measures:
  • Axial growth

Secondary Outcome Measures:
  • Myopia progression

Estimated Enrollment: 90
Study Start Date: October 2003
Estimated Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   8 Years to 13 Years
Genders Eligible for Study:   Both
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)

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00263471     History of Changes
Other Study ID Numbers: 2612-2320
Study First Received: December 6, 2005
Last Updated: December 13, 2005
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014