Myopia; Refractive ErrorARCTICNCT07155551
Measuring Changes In Choroidal Thickness Induced By Prototype Soft Contact Lenses Worn For 1 Hour
A study testing Lens A, Lens B and Lens C in people with Myopia; Refractive Error, run by Myoptechs, Inc at 1 site in Canada.
Trial summary
The objective of the study is to evaluate the short-term change in choroidal thickness induced by 3 prototype soft contact lenses for people with myopia. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Myopia; Refractive Error
- What is being tested?
- Lens A, Lens B and Lens C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 25 Aug 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Are 18-25 years of age (inclusive) and have full legal capacity to volunteer; Have read (or be read to) and signed the information and consent form; Habitually wear soft contact lenses or are spectacle wearers with previous experience of soft contact lens wear;
- Are myopic with both eyes having a vertex corrected spherical equivalent non-cycloplegic refraction of at least -0.50 DS and no more than -4.50 DS;
- Achieve at least LogMAR +0.10 with spherical equivalent refraction in each eye;
- Are willing and able to maintain the appointment schedule and follow the measurement visit instructions which include no use of caffeine drinks, alcohol or other stimulants 12 hours before each measurement visit and no smoking or use of recreational cannabis 24 hours before the study visit;
- Have not used a myopia control treatment within 2 years prior to Visit 0 (this includes multifocal spectacle or contact lens wear, orthokeratology, or atropine);
- Typically sleeps at least 7 hours per night.
Who cannot join
- Participating in any concurrent clinical or research study;
- Have astigmatism of more than 1.00 DC in either eye as per non-cycloplegic refraction;
- Have amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency;
- Have any known active* ocular disease and/or infection;
- Have a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism, and active allergies;
- Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. Examples include antihistamine, atropine eye drops;
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- Have known sensitivity to the sodium fluorescein diagnostic pharmaceutical to be used in the study;
- Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
- Have undergone strabismus surgery, refractive error surgery or intraocular surgery;
- Are an employee of the Centre for Ocular Research \& Education directly involved in this study (i.e. on the delegation log).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre for Ocular Research and Education at the School of Optometry and Vision Science at Waterloo University
Waterloo, Ontario, N2L 3G1
Jill Woods, 519 888 4567 ext. 36743, jwoods@uwaterloo.ca
Doerte Luensmann, 519 888 4567 ext. 47312, doerte.luensmann@uwaterloo.ca
About this study
The objective of the study is to evaluate the short-term change in choroidal thickness induced by 3 prototype soft contact lenses for people with myopia.
- Conditions
- Myopia; Refractive Error
- Being tested
- Lens A, Lens B, Lens C
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lens ADevice
Lens A of Study P/883/24/MO
Lens BDevice
Lens B of Study P/883/24/MO
Lens CDevice
Lens C of Study P/883/24/MO
| Study group | Role | What they receive |
|---|---|---|
| Lens A | Experimental | Not described Receives: Device: Lens A; Device: Lens B; Device: Lens C |
| Lens B | Experimental | Not described Receives: Device: Lens A; Device: Lens B; Device: Lens C |
| Lens C | Experimental | Not described Receives: Device: Lens A; Device: Lens B; Device: Lens C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Choroidal Thickness from Baseline to After 1 Hour of Contact Lens Wear
The change in sub-foveal choroidal thickness for the 3 study contact lenses will be compared from baseline to after 1 hour of contact lens wear. Measurements will be conducted on the right eye using a swept-source Optical Coherence Tomographer and measured in micrometers.
Measured: After 1 hour of wearing each contact lens
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start25 Aug 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia; Refractive ErrorStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- We understand that this falls outside the realm of a feasibility study given the intended sample size of 20 subjects. That being stated we selected Other in our resubmission, because in our opinion none of the "Primary Purpose" selection options fit the intent of studying the contact lenses impact on the choroid to detect the eyes' ability to respond to the defocus created by these lenses. These data will help inform further development decisions for an eventual clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myoptechs, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155551
- Sponsor's protocol ID
- P/883/24/MO
- Acronym
- ARCTIC
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The results are regarded as confidential to our business as Sponsor, and confidential for the selection of one device to use in a future efficacy trial. There are no plans for a public data repository for this study.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Changes In Choroidal Thickness Induced By Prototype Soft Contact Lenses Worn For 1 Hour
- ClinicalTrials.gov ID
- NCT07155551
- Acronym / sponsor ID
- ARCTIC / P/883/24/MO
- Conditions
- Myopia; Refractive Error
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Myoptechs, IncIndustry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Study start
- 25 Aug 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Sep 2025 (actual)
- 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 objective of the study is to evaluate the short-term change in choroidal thickness induced by 3 prototype soft contact lenses for people with myopia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- We understand that this falls outside the realm of a feasibility study given the intended sample size of 20 subjects. That being stated we selected Other in our resubmission, because in our opinion none of the "Primary Purpose" selection options fit the intent of studying the contact lenses impact on the choroid to detect the eyes' ability to respond to the defocus created by these lenses. These data will help inform further development decisions for an eventual clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Lens A | Experimental | Device: Lens A, Device: Lens B, Device: Lens C |
| Lens B | Experimental | Device: Lens A, Device: Lens B, Device: Lens C |
| Lens C | Experimental | Device: Lens A, Device: Lens B, Device: Lens C |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Are 18-25 years of age (inclusive) and have full legal capacity to volunteer; Have read (or be read to) and signed the information and consent form; Habitually wear soft contact lenses or are spectacle wearers with previous experience of soft contact lens wear;
- Are myopic with both eyes having a vertex corrected spherical equivalent non-cycloplegic refraction of at least -0.50 DS and no more than -4.50 DS;
- Achieve at least LogMAR +0.10 with spherical equivalent refraction in each eye;
- Are willing and able to maintain the appointment schedule and follow the measurement visit instructions which include no use of caffeine drinks, alcohol or other stimulants 12 hours before each measurement visit and no smoking or use of recreational cannabis 24 hours before the study visit;
- Have not used a myopia control treatment within 2 years prior to Visit 0 (this includes multifocal spectacle or contact lens wear, orthokeratology, or atropine);
Key exclusion criteria (10 listed)
- Participating in any concurrent clinical or research study;
- Have astigmatism of more than 1.00 DC in either eye as per non-cycloplegic refraction;
- Have amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency;
- Have any known active* ocular disease and/or infection;
- Have a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism, and active allergies;
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 |
|---|---|---|
| Lens ALens A of Study P/883/24/MO | Device | Lens A, Lens B, Lens C |
| Lens BLens B of Study P/883/24/MO | Device | Lens A, Lens B, Lens C |
| Lens CLens C of Study P/883/24/MO | Device | Lens A, Lens B, Lens C |
Primary outcome
Change in Choroidal Thickness from Baseline to After 1 Hour of Contact Lens Wear
Time frame: After 1 hour of wearing each contact lens
The change in sub-foveal choroidal thickness for the 3 study contact lenses will be compared from baseline to after 1 hour of contact lens wear. Measurements will be conducted on the right eye using a swept-source Optical Coherence Tomographer and measured in micrometers.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No. The results are regarded as confidential to our business as Sponsor, and confidential for the selection of one device to use in a future efficacy trial. There are no plans for a public data repository for this study.
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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.
Centre for Ocular Research and Education at the School of Optometry and Vision Science at Waterloo University
Waterloo, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lens A, Lens B and Lens C in people with Myopia; Refractive Error, run by Myoptechs, Inc at 1 site in Canada.
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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 4 Sep 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Choroidal Thickness from Baseline to After 1 Hour of Contact Lens Wear (time frame: After 1 hour of wearing each contact lens). 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 4 Sep 2025.