Echothiophate Iodide for the Prevention of Progression of Myopia

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

Study Overview

• Status: Withdrawn
• Conditions: Myopia
• Intervention / Treatment: Drug: Echothiophate Iodide 0.03% Ophthalmic Solution; Drug: Carboxymethylcellulose Sodium (0.5%)

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Danbury Eye Physicians & Surgeons, PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Danbury Eye Physicians & Surgeons, PC
• Investigators: Principal Investigator: Stephen A Mathias, MD, MPH, Danbury Eye Physicians & Surgeons, PC

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: September 7, 2015
• First Submitted That Met QC Criteria: September 7, 2015
• First Posted (Estimated): September 9, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Enzyme Inhibitors; Neurotransmitter Agents; Cholinergic Agents; Parasympathomimetics; Laxatives; Cholinesterase Inhibitors; Miotics; Pharmaceutical Solutions; Ophthalmic Solutions; Carboxymethylcellulose Sodium; Echothiophate Iodide
• Other Study ID Numbers: DEPS 001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No