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Echothiophate Iodide for the Prevention of Progression of Myopia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02544529
Recruitment Status : Unknown
Verified September 2015 by Stephen Mathias, MD, MPH, FAAP, Danbury Eye Physicians & Surgeons, PC.
Recruitment status was:  Not yet recruiting
First Posted : September 9, 2015
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):
Stephen Mathias, MD, MPH, FAAP, Danbury Eye Physicians & Surgeons, PC

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.

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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


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




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544529


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

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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    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases
Iodine
Carboxymethylcellulose Sodium
Ophthalmic Solutions
Pharmaceutical Solutions
Echothiophate Iodide
Laxatives
Gastrointestinal Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Parasympathomimetics