Echothiophate Iodide for the Prevention of Progression of Myopia

Myopia Clinical Trial

Official title:

Echothiophate Iodide for the Prevention of Progression of Myopia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02544529
• Other study ID #: DEPS 001
• Status: Not yet recruiting
• Phase: Phase 4
• First received: September 7, 2015
• Last updated: September 7, 2015
• Start date: June 2016
• Est. completion date: October 2017

Study information

• Verified date: September 2015
• Source: Danbury Eye Physicians & Surgeons, PC
• Contact: Stephen A Mathias, MD,MPH
• Phone: 203-791-2020
• Email: mdeyes[@]comcast.net
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 33
• Est. completion date: October 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 15 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• Echothiophate Iodide 0.03% Ophthalmic Solution
one drop to each eye three times per week for 18 weeks
• Carboxymethylcellulose Sodium (0.5%)
one drop to each eye three times per week for 18 weeks

Locations

Country	Name	City	State
United States	Danbury Eye Physicians & Surgeons, PC	Danbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Danbury Eye Physicians & Surgeons, PC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cycloplegic Refraction	Cycloplegic refraction change after 12 weeks of treatment with drug	12 weeks	No
Secondary	Axial Length	Change in axial length after 12 weeks of treatment	12 weeks	No
Secondary	Choroidal Thickness	Change in choroidal thickness after 12 weeks of treatment	12 weeks	No