MyopiaPhase 4NCT02544529
Echothiophate Iodide for the Prevention of Progression of Myopia
A Phase 4 study testing Echothiophate Iodide 0.03% Ophthalmic Solution and Carboxymethylcellulose Sodium (0.5%) in people with Myopia, run by Danbury Eye Physicians & Surgeons, PC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 9 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Echothiophate Iodide 0.03% Ophthalmic Solution and Carboxymethylcellulose Sodium (0.5%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2016to 1 Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Danbury Eye Physicians & Surgeons, PC
Danbury, Connecticut, 06810
About this study
The purpose of this study is to test the hypothesis that myopia progression can be slowed or prevented by low dose Echothiophate Iodide.
Read the 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.
- Conditions
- Myopia
- Being tested
- Echothiophate Iodide 0.03% Ophthalmic Solution, Carboxymethylcellulose Sodium (0.5%)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echothiophate Iodide 0.03% Ophthalmic SolutionDrug
Also called Phospholine Iodiede 0.03% ophththalmic solution
one drop to each eye three times per week for 18 weeks
Carboxymethylcellulose Sodium (0.5%)Drug
Also called Refresh
one drop to each eye three times per week for 18 weeks
| Study group | Role | What they receive |
|---|---|---|
| Echothiophate Iodide | Experimental | Echothiophate Iodide 0.03% one drop to each eye three times per week for 18 weeks Receives: 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 Receives: Drug: Carboxymethylcellulose Sodium (0.5%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycloplegic Refraction
Cycloplegic refraction change after 12 weeks of treatment with drug
Measured: 12 weeks
Secondary outcomes (2)
Axial Length
Change in axial length after 12 weeks of treatment
Measured: 12 weeks
Choroidal Thickness
Change in choroidal thickness after 12 weeks of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study start1 Jun 2016 (estimated)
- Primary completion1 Jun 2016
- Study completion1 Jun 2016
Why it stopped: No funding available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danbury Eye Physicians & Surgeons, PC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Smit, Danbury Eye Physicians & Surgeons, PC
- Investigators
- Stephen A Mathias, MD, MPH, Principal investigator, Danbury Eye Physicians & Surgeons, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544529
- Sponsor's protocol ID
- DEPS 001
- Status last verified
- Sep 2015
- First submitted
- 7 Sep 2015
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echothiophate Iodide for the Prevention of Progression of Myopia
- ClinicalTrials.gov ID
- NCT02544529
- Acronym / sponsor ID
- DEPS 001
- Conditions
- Myopia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Danbury Eye Physicians & Surgeons, PCUniversity, hospital or other
- Study start
- 1 Jun 2016 (estimated)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echothiophate Iodide | Experimental | Drug: Echothiophate Iodide 0.03% Ophthalmic SolutionEchothiophate Iodide 0.03% one drop to each eye three times per week for 18 weeks |
| Carboxymethylcellulose Sodium (0.5%) | Placebo comparator | Drug: Carboxymethylcellulose Sodium (0.5%)Carboxymethylcellulose Sodium (0.5%) one drop to each eye three times per week for 18 weeks |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echothiophate Iodide 0.03% Ophthalmic SolutionAlso: Phospholine Iodiede 0.03% ophththalmic solutionone drop to each eye three times per week for 18 weeks | Drug | Echothiophate Iodide |
| Carboxymethylcellulose Sodium (0.5%)Also: Refreshone drop to each eye three times per week for 18 weeks | Drug | Carboxymethylcellulose Sodium (0.5%) |
Primary outcome
Cycloplegic Refraction
Time frame: 12 weeks
Cycloplegic refraction change after 12 weeks of treatment with drug
2 secondary outcomes
Axial Length
Time frame: 12 weeks
Choroidal Thickness
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen A Mathias, MD, MPH principal investigator
Danbury Eye Physicians & Surgeons, PC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Echothiophate Iodide 0.03% Ophthalmic Solution and Carboxymethylcellulose Sodium (0.5%) in people with Myopia, run by Danbury Eye Physicians & Surgeons, PC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cycloplegic Refraction (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.