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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02544529
Other study ID # DEPS 001
Secondary ID
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


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
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