Echothiophate Iodide for the Prevention of Progression of... | NCT02544529

Studies
Echothiophate Iodide for the Prevention of Progression of Myopia

NCT02544529

Sponsor

Danbury Eye Physicians & Surgeons, PC

Status

Withdrawn

Last Update Posted

Feb 7, 2025Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Myopia

Interventions

Echothiophate Iodide 0.03% Ophthalmic Solution
Carboxymethylcellulose Sodium (0.5%)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No funding available

Expanded Access Info

Start Date

Jun 1, 2016Estimated

Primary Completion Date

Jun 1, 2016Actual

Completion Date

Jun 1, 2016Actual

First Submitted Date

Sep 7, 2015

First Submission Date that Met QC Criteria

Sep 7, 2015

First Posted Date

Sep 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2025

Last Update Posted Date

Feb 7, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Angela Smit, Director of Clinical Research Operations, Danbury Eye Physicians & Surgeons, PCPrincipal Investigator

Lead Sponsor

Danbury Eye Physicians & Surgeons, PCOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Echothiophate Iodide 0.03% Ophthalmic Solution	Drug	one drop to each eye three times per week for 18 weeks	Echothiophate Iodide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cycloplegic Refraction	Cycloplegic refraction change after 12 weeks of treatment with drug	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Axial Length	Change in axial length after 12 weeks of treatment	12 weeks
Choroidal Thickness	Change in choroidal thickness after 12 weeks of treatment

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen A Mathias, MD, MPH	Danbury Eye Physicians & Surgeons, PC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Danbury Eye Physicians & Surgeons, PC		Danbury	Connecticut	06810	United States

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004456	Echothiophate Iodide
D009883	Ophthalmic Solutions
D002266	Carboxymethylcellulose Sodium

Ancestor Terms

ID	Term
D063086	Organothiophosphates
D010755	Organophosphates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided