Echothiophate Iodide for the Prevention of Progression of Myopia

• ClinicalTrials.gov Identifier: NCT02544529
• Recruitment Status: Unknown
• First Posted: September 9, 2015
• Last Update Posted: September 9, 2015
• Sponsor: Danbury Eye Physicians & Surgeons, PC
• Information provided by (Responsible Party): Stephen Mathias, MD, MPH, FAAP, Danbury Eye Physicians & Surgeons, PC

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Myopia	Drug: Echothiophate Iodide 0.03% Ophthalmic Solution; Drug: Carboxymethylcellulose Sodium (0.5%)	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Echothiophate Iodide for the Prevention of Progression of Myopia
• Study Start Date: June 2016
• Estimated Primary Completion Date: June 2017
• Estimated Study Completion Date: October 2017

Arms and Interventions

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 Name: 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 Name: Refresh

Outcome Measures

Primary Outcome Measures :

1. Cycloplegic Refraction [ Time Frame: 12 weeks ]
   Cycloplegic refraction change after 12 weeks of treatment with drug

Secondary Outcome Measures :

1. Axial Length [ Time Frame: 12 weeks ]
   Change in axial length after 12 weeks of treatment
2. Choroidal Thickness [ Time Frame: 12 weeks ]
   Change in choroidal thickness after 12 weeks of treatment

Eligibility Criteria

• Ages Eligible for Study: 9 Years to 15 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Contacts

Contact: Stephen A Mathias, MD,MPH; 203-791-2020; mdeyes@comcast.net

Contact: Stephen A Mathias, MD, MPH; 203-791-2020; mdeyes@comcast.net

Locations

United States, Connecticut

Danbury Eye Physicians & Surgeons, PC

Danbury, Connecticut, United States, 06810

Contact: Linda Bennett 203-791-2020 ext 250 LBennnet@Danburyeye.com

Contact: Stephen A Mathias, MD 203-791-2020 mdeyes@comcast.net

Sponsors and Collaborators

Danbury Eye Physicians & Surgeons, PC

Investigators

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

More Information

• Responsible Party: Stephen Mathias, MD, MPH, FAAP, Vice President, Danbury Eye Physicians & Surgeons, PC
• ClinicalTrials.gov Identifier: NCT02544529
• Other Study ID Numbers: DEPS 001
• First Posted: September 9, 2015
• Last Update Posted: September 9, 2015
• Last Verified: September 2015

Additional relevant MeSH terms:

Myopia; Refractive Errors; Eye Diseases; Carboxymethylcellulose Sodium; Pharmaceutical Solutions; Ophthalmic Solutions; Echothiophate Iodide; Laxatives; Gastrointestinal Agents; Cholinesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Miotics; Autonomic Agents; Peripheral Nervous System Agents; Parasympathomimetics