Overview

This trial is active, not recruiting.

Condition myopia
Treatment 7-methylxanthine
Phase phase 2
Sponsor Trier Research Laboratories
Collaborator Generalkonsul Einar Høyvalds Fond
Start date October 2003
End date March 2006
Trial size 90 participants
Trial identifier NCT00263471, 2612-2320

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose prevention

Primary Outcomes

Measure
Axial growth
time frame:

Secondary Outcomes

Measure
Myopia progression
time frame:

Eligibility Criteria

Male or female participants from 8 years up to 13 years old.

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) -

Additional Information

Official title Phase 2 Study of the Effect of 7-Methylxanthine on the Progression of Childhood Myopia
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2005.
Information provided to ClinicalTrials.gov by Trier Research Laboratories.