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Echothiophate Iodide for the Prevention of Progression of Myopia

Primary Purpose

Myopia

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Echothiophate Iodide 0.03% Ophthalmic Solution
Carboxymethylcellulose Sodium (0.5%)
Sponsored by
Danbury Eye Physicians & Surgeons, PC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopia

Eligibility Criteria

9 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Danbury Eye Physicians & Surgeons, PC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Echothiophate Iodide

Carboxymethylcellulose Sodium (0.5%)

Arm Description

Echothiophate Iodide 0.03% 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

Outcomes

Primary Outcome Measures

Cycloplegic Refraction
Cycloplegic refraction change after 12 weeks of treatment with drug

Secondary Outcome Measures

Axial Length
Change in axial length after 12 weeks of treatment
Choroidal Thickness
Change in choroidal thickness after 12 weeks of treatment

Full Information

First Posted
September 7, 2015
Last Updated
September 7, 2015
Sponsor
Danbury Eye Physicians & Surgeons, PC
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1. Study Identification

Unique Protocol Identification Number
NCT02544529
Brief Title
Echothiophate Iodide for the Prevention of Progression of Myopia
Official Title
Echothiophate Iodide for the Prevention of Progression of Myopia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danbury Eye Physicians & Surgeons, PC

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Echothiophate Iodide
Arm Type
Experimental
Arm Description
Echothiophate Iodide 0.03% one drop to each eye three times per week for 18 weeks
Arm Title
Carboxymethylcellulose Sodium (0.5%)
Arm Type
Placebo Comparator
Arm Description
Carboxymethylcellulose Sodium (0.5%) one drop to each eye three times per week for 18 weeks
Intervention Type
Drug
Intervention Name(s)
Echothiophate Iodide 0.03% Ophthalmic Solution
Other Intervention Name(s)
Phospholine Iodiede 0.03% ophththalmic solution
Intervention Description
one drop to each eye three times per week for 18 weeks
Intervention Type
Drug
Intervention Name(s)
Carboxymethylcellulose Sodium (0.5%)
Other Intervention Name(s)
Refresh
Intervention Description
one drop to each eye three times per week for 18 weeks
Primary Outcome Measure Information:
Title
Cycloplegic Refraction
Description
Cycloplegic refraction change after 12 weeks of treatment with drug
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Axial Length
Description
Change in axial length after 12 weeks of treatment
Time Frame
12 weeks
Title
Choroidal Thickness
Description
Change in choroidal thickness after 12 weeks of treatment
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen A Mathias, MD,MPH
Phone
203-791-2020
Email
mdeyes@comcast.net
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen A Mathias, MD, MPH
Phone
203-791-2020
Email
mdeyes@comcast.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen A Mathias, MD, MPH
Organizational Affiliation
Danbury Eye Physicians & Surgeons, PC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danbury Eye Physicians & Surgeons, PC
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Bennett
Phone
203-791-2020
Ext
250
Email
LBennnet@Danburyeye.com
First Name & Middle Initial & Last Name & Degree
Stephen A Mathias, MD
Phone
203-791-2020
Email
mdeyes@comcast.net

12. IPD Sharing Statement

Learn more about this trial

Echothiophate Iodide for the Prevention of Progression of Myopia

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