Myopia Progression and the Effect of 7-Methylxanthine

Myopia Clinical Trial

Official title:

Phase 2 Study of the Effect of 7-Methylxanthine on the Progression of Childhood Myopia

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00263471
• Other study ID #: 2612-2320
• Status: Unknown status
• Phase: Phase 2
• First received: December 6, 2005
• Last updated: December 13, 2005
• Start date: October 2003
• Est. completion date: March 2006

Study information

• Verified date: October 2003
• Source: Trier Research Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 90
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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)

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• 7-methylxanthine

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Trier Research Laboratories	Chr. Andersen og hustru Ingeborg Andersen, f. Schmidts legat (fond) oprettet af deres datter, frk. Lilli Ellen Andersen., Generalkonsul Einar Høyvalds Fond, Jørgen Bagenkop Nielsens Myopi-Fond

References & Publications (1)

Trier K, Olsen EB, Kobayashi T, Ribel-Madsen SM. Biochemical and ultrastructural changes in rabbit sclera after treatment with 7-methylxanthine, theobromine, acetazolamide, or L-ornithine. Br J Ophthalmol. 1999 Dec;83(12):1370-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial growth
Secondary	Myopia progression