Echothiophate Iodide for the Prevention of Progression of Myopia

Danbury Eye Physicians & Surgeons, PC

Status and phase: Withdrawn; Phase 4

Conditions: Myopia

Treatments: Drug: Carboxymethylcellulose Sodium (0.5%); Drug: Echothiophate Iodide 0.03% Ophthalmic Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02544529

DEPS 001

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 9 to 15 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Echothiophate Iodide

Experimental group

Description:

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

Treatment:

Drug: Echothiophate Iodide 0.03% Ophthalmic Solution

Carboxymethylcellulose Sodium (0.5%)

Placebo Comparator group

Description:

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

Treatment:

Drug: Carboxymethylcellulose Sodium (0.5%)