Echothiophate Iodide for the Prevention of Progression of Myopia

Study Overview
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Brief Summary
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The purpose of this study is to test the hypothesis that myopia progression can be slowed or prevented by low dose Echothiophate Iodide.

Detailed Description
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This pilot study is designed to establish proof of concept of a method to either slow or stop the progression of myopia in children between the ages of 8 and 15 years by using Echothiophate Iodide eye drops to alter the relationship between focusing (accommodation), eye alignment, and peripheral blurring. Echothiophate Iodide 0.03% eye drops have been used for years for the treatment of accommodative esotropia in children. A prospective double blind randomized study of 33 children with active development of myopia will be divided into a treatment group of 22 and a control group of 11. They will be treated for 18 weeks with four planned visits at 6 week intervals. The progression of myopia will be measured by a determination of the length of the eye (axial length measured by the IOL Master) and cycloplegic refractions. Influencing factors such as corneal changes, lens changes and macular choroidal thickness will be monitored for any significance. If successful, a larger and longer study to slow the rate of myopia with echothiophate iodide will be done in order to decrease the world's incidence of myopia currently at 25-33% in western countries and 85% in Asian countries. This would also reduce the financial burden of glasses and contact lenses as well as decrease the incidence of pathological eye disease due to high myopia.

Official Title
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Echothiophate Iodide for the Prevention of Progression of Myopia

Conditions
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Myopia

Intervention / Treatment
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* Drug: Echothiophate Iodide 0.03% Ophthalmic Solution
* Drug: Carboxymethylcellulose Sodium (0.5%)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy children between 8-15 years of age Documentation of progression of myopia within the 12 months prior to enrollment Written informed consent/Assent for the study Exclusion Criteria: Any history of retinopathy of prematurity, glaucoma, cataracts, corneal disease, uveitis, manifest strabismus, nystagmus or ocular trauma Any history of unstable asthma, diabetes, or juvenile idiopathic arthritis Asthma must be stable for three months prior to enrollment if utilizing oral or inhaled steroids Systemic muscarinic agents, steroids, or anticholinesterase agents. Benzalkonium chloride preservative allergy. Astigmatism >0.75D Anisometropia >1.50D Pregnancy or a positive pregnancy test at the screening visit.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Echothiophate Iodide<br>Echothiophate Iodide 0.03% one drop to each eye three times per week for 18 weeks | Drug: Echothiophate Iodide 0.03% Ophthalmic Solution<br>* one drop to each eye three times per week for 18 weeks<br>* Other names: Phospholine Iodiede 0.03% ophththalmic solution;|
| Placebo Comparator: Carboxymethylcellulose Sodium (0.5%)<br>Carboxymethylcellulose Sodium (0.5%) one drop to each eye three times per week for 18 weeks | Drug: Carboxymethylcellulose Sodium (0.5%)<br>* one drop to each eye three times per week for 18 weeks<br>* Other names: Refresh;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycloplegic Refraction | Cycloplegic refraction change after 12 weeks of treatment with drug | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial Length | Change in axial length after 12 weeks of treatment | 12 weeks | 
| Choroidal Thickness | Change in choroidal thickness after 12 weeks of treatment | 12 weeks |