Echothiophate Iodide for the Prevention of Progression of Myopia

Phase 4

Withdrawn

• Conditions: Myopia
• Interventions: Drug: Echothiophate Iodide 0.03% Ophthalmic Solution; Drug: Carboxymethylcellulose Sodium (0.5%)

• Registration Number: NCT02544529
• Lead Sponsor: Danbury Eye Physicians & Surgeons, PC

Brief Summary

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

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.

Study Timeline

• Status Verified: 2015-09
• Study First Submitted: 2015-09-07
• Study First Submitted QC: 2015-09-07
• Study First Posted: 2015-09-09
• Study Start: 2016-06-01
• Primary Completion: 2016-06-01
• Study Completion: 2016-06-01
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Echothiophate Iodide	Echothiophate Iodide 0.03% Ophthalmic Solution	Echothiophate Iodide 0.03% one drop to each eye three times per week for 18 weeks
Carboxymethylcellulose Sodium (0.5%)	Carboxymethylcellulose Sodium (0.5%)	Carboxymethylcellulose Sodium (0.5%) one drop to each eye three times per week for 18 weeks

Primary Outcome Measures

Name	Time	Method
Cycloplegic Refraction	12 weeks	Cycloplegic refraction change after 12 weeks of treatment with drug

Secondary Outcome Measures

Name	Time	Method
Axial Length	12 weeks	Change in axial length after 12 weeks of treatment
Choroidal Thickness	12 weeks	Change in choroidal thickness after 12 weeks of treatment

Trial Locations

Locations (1)

Danbury Eye Physicians & Surgeons, PC; 🇺🇸 Danbury, Connecticut, United States