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

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 Overview

• Status: Recruiting
• Conditions: Myopia; Refractive Error
• Intervention / Treatment: Device: Lens A; Device: Lens B; Device: Lens C

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Recruiting
      • Centre for Ocular Research and Education at the School of Optometry and Vision Science at Waterloo University
      • Contact: Jill Woods; Phone Number: 36743 519 888 4567; Email: jwoods@uwaterloo.ca
      • Contact: Doerte Luensmann; Phone Number: 47312 519 888 4567; Email: doerte.luensmann@uwaterloo.ca
      • Principal Investigator: Lyndon Jones, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens A	Device: Lens A; Lens A of Study P/883/24/MO; Device: Lens B; Lens B of Study P/883/24/MO; Device: Lens C; Lens C of Study P/883/24/MO
Experimental: Lens B	Device: Lens A; Lens A of Study P/883/24/MO; Device: Lens B; Lens B of Study P/883/24/MO; Device: Lens C; Lens C of Study P/883/24/MO
Experimental: Lens C	Device: Lens A; Lens A of Study P/883/24/MO; Device: Lens B; Lens B of Study P/883/24/MO; Device: Lens C; Lens C of Study P/883/24/MO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After 1 hour of wearing each contact lens

Collaborators and Investigators

• Sponsor: Myoptechs, Inc
• Collaborators: University of Waterloo School of Optometry and Vision Science

Study record dates

Study Major Dates

• Study Start (Estimated): August 25, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 15, 2025
• First Submitted That Met QC Criteria: August 27, 2025
• First Posted (Estimated): September 4, 2025

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Myopia; Refractive Errors
• Other Study ID Numbers: P/883/24/MO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes