MyopiaPhase 2NCT00263471
Myopia Progression and the Effect of 7-Methylxanthine
A Phase 2 study testing 7-methylxanthine in people with Myopia, run by Trier Research Laboratories.
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. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Myopia
- What is being tested?
- 7-methylxanthine
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Mar 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children in the age 8-13 years with myopia and an axial growth rate of 0.15 mm or more per year.
- -
Who cannot join
- Severe general ailment (for example diabetes, epilepsy, psychiatric disease) Eye diseases (for example cataract, keratoconus, chronic iritis, glaucoma)
- -
About this study
Official title: Phase 2 Study of the Effect of 7-Methylxanthine on the Progression of Childhood Myopia
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.
Read the 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.
- Conditions
- Myopia
- Being tested
- 7-methylxanthine
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-methylxanthineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial growth
Secondary outcomes (1)
Myopia progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2005 (estimated)
- Study startOct 2003
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Trier Research Laboratories
- Sponsor type
- University, hospital or other
- 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.
- Investigators
- Klaus Trier, MD, Study chair, Trier Research Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263471
- Sponsor's protocol ID
- 2612-2320
- Status last verified
- Oct 2003
- First submitted
- 6 Dec 2005
- Last updated
- 14 Dec 2005
- Results posted
- No
Publications
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. doi: 10.1136/bjo.83.12.1370.
PubMed 10574816Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.
PubMed 36809645Cui D, Trier K, Munk Ribel-Madsen S. Effect of day length on eye growth, myopia progression, and change of corneal power in myopic children. Ophthalmology. 2013 May;120(5):1074-9. doi: 10.1016/j.ophtha.2012.10.022. Epub 2013 Feb 4.
PubMed 23380471
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of the Effect of 7-Methylxanthine on the Progression of Childhood Myopia
- ClinicalTrials.gov ID
- NCT00263471
- Acronym / sponsor ID
- 2612-2320
- Conditions
- Myopia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants
- Lead sponsor
- Trier Research LaboratoriesUniversity, hospital or other
- 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.
- Study start
- Oct 2003
- Study completion
- Mar 2006
- First posted
- 8 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children in the age 8-13 years with myopia and an axial growth rate of 0.15 mm or more per year.
- -
Key exclusion criteria (2 listed)
- Severe general ailment (for example diabetes, epilepsy, psychiatric disease) Eye diseases (for example cataract, keratoconus, chronic iritis, glaucoma)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7-methylxanthine | Drug | – |
Primary outcome
Axial growth
1 secondary outcome
Myopia progression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2005.
- Background: PubMed 10574816Trier 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. doi: 10.1136/bjo.83.12.1370.
- Derived from this study: PubMed 36809645Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.
- Derived from this study: PubMed 23380471Cui D, Trier K, Munk Ribel-Madsen S. Effect of day length on eye growth, myopia progression, and change of corneal power in myopic children. Ophthalmology. 2013 May;120(5):1074-9. doi: 10.1016/j.ophtha.2012.10.022. Epub 2013 Feb 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Trier, MD study chair
Trier Research Laboratories
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 7-methylxanthine in people with Myopia, run by Trier Research Laboratories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial growth. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00263471, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2005.