Echothiophate Iodide for the Prevention of Progression of Myopia

NCT02544529 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: DEPS 001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Cycloplegic Refraction

  Cycloplegic refraction change after 12 weeks of treatment with drug

  12 weeks

Secondary Outcomes (2)

• Axial Length

  12 weeks

• Choroidal Thickness

  12 weeks

Study Arms (2)

Echothiophate Iodide

EXPERIMENTAL

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

Drug: Echothiophate Iodide 0.03% Ophthalmic Solution

Carboxymethylcellulose Sodium (0.5%)

PLACEBO COMPARATOR

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

Drug: Carboxymethylcellulose Sodium (0.5%)

Interventions

Echothiophate Iodide 0.03% Ophthalmic Solution DRUG

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

Also known as: Phospholine Iodiede 0.03% ophththalmic solution

Echothiophate Iodide

Carboxymethylcellulose Sodium (0.5%) DRUG

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

Also known as: Refresh

Carboxymethylcellulose Sodium (0.5%)

Eligibility Criteria

• Age: 9 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danbury Eye Physicians & Surgeons, PC: lead

Study Sites (1)

Danbury Eye Physicians & Surgeons, PC

Danbury, Connecticut, 06810, United States

Location

MeSH Terms

Conditions

Myopia

Interventions

Echothiophate Iodide; Ophthalmic Solutions; Carboxymethylcellulose Sodium

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Methylcellulose; Cellulose; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Stephen A Mathias, MD, MPH

  Danbury Eye Physicians & Surgeons, PC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research Operations

Study Record Dates

• First Submitted: September 7, 2015
• First Posted: September 9, 2015
• Study Start: June 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 7, 2025

Record last verified: 2015-09

Locations

US (1)