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NCT Number: NCT07155551

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

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.

Recruiting

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Ocular Research and Education at the School of Optometry and Vision Science at Waterloo University

Waterloo, Ontario, N2L 3G1, Canada

Location status: Recruiting

Location contact

Doerte Luensmann

CONTACT

[email protected]

519 888 4567 ext. 47312

Jill Woods

CONTACT

[email protected]

519 888 4567 ext. 36743

Lyndon Jones, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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).

Treatment and study plan

Lens A

Device

Lens A of Study P/883/24/MO

Lens B

Device

Lens B of Study P/883/24/MO

Lens C

Device

Lens C of Study P/883/24/MO

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Myoptechs, Inc

Industry

Collaborators

  • University of Waterloo School of Optometry and Vision Science

Registry information

Acronym: ARCTIC

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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