ClinicalTrials.gg
RecruitingNCT07155551ARCTICUpdated Sep 4, 2025

Measuring Changes In Choroidal Thickness Induced By Prototype Soft Contact Lenses Worn For 1 Hour

An interventional study of Lens A and Lens B in Myopia; Refractive Error, sponsored by Myoptechs, Inc. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-09-04.

Sponsored by Myoptechs, Inc · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Myopia; Refractive Error
03

In context

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

This study's planned enrollment of 20 is below the median of 78 across 923 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Myoptechs, Inc is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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;
  • 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).
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Lens A

    Device: Lens A · Device: Lens B · Device: Lens C

  • Experimental
    Lens B

    Device: Lens A · Device: Lens B · Device: Lens C

  • Experimental
    Lens C

    Device: Lens A · Device: Lens B · Device: Lens C

Interventions

  • DeviceLens A

    Lens A of Study P/883/24/MO

  • DeviceLens B

    Lens B of Study P/883/24/MO

  • DeviceLens C

    Lens C of Study P/883/24/MO

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: After 1 hour of wearing each contact lens

07

Study locations

1 of 1 sites recruiting
  • Centre for Ocular Research and Education at the School of Optometry and Vision Science at Waterloo University
    Waterloo, Ontario N2L 3G1, Canada
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07155551
Lead sponsor
Myoptechs, Inc
Collaborators
University of Waterloo
Responsible party
Sponsor
First posted
Sep 4, 2025
Start date
Aug 25, 2025 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Sep 4, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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