Echothiophate Iodide for the Prevention of Progression of Myopia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2016-06-01

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.

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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.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Echothiophate Iodide

Echothiophate Iodide 0.03% one drop to each eye three times per week for 18 weeks

Group Type EXPERIMENTAL

Echothiophate Iodide 0.03% Ophthalmic Solution

Intervention Type DRUG

one drop to each eye three times per week for 18 weeks

Carboxymethylcellulose Sodium (0.5%)

Carboxymethylcellulose Sodium (0.5%) one drop to each eye three times per week for 18 weeks

Group Type PLACEBO_COMPARATOR

Carboxymethylcellulose Sodium (0.5%)

Intervention Type DRUG

one drop to each eye three times per week for 18 weeks

Interventions

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Echothiophate Iodide 0.03% Ophthalmic Solution

one drop to each eye three times per week for 18 weeks

Intervention Type DRUG

Carboxymethylcellulose Sodium (0.5%)

one drop to each eye three times per week for 18 weeks

Intervention Type DRUG

Other Intervention Names

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Phospholine Iodiede 0.03% ophththalmic solution Refresh

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.

Minimum Eligible Age

9 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes