Recruiting

Contact Lenses

Sponsor:

Myoptechs, Inc

Code:

NCT07155551

Conditions

Myopia; Refractive Error

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Not accepted

Interventions

Lens A

Lens B

Lens C

Study Details

Brief 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.

Conditions

Myopia; Refractive Error

Study ID

NCT07155551

Start date

Aug 25, 2025

Status verified date

Aug, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Lens A

experimental: Lens B

experimental: Lens C

Interventions

Lens A

Lens A of Study P/883/24/MO

Lens B

Lens B of Study P/883/24/MO

Lens C

Lens C of Study P/883/24/MO

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 ]

Central Contacts and Locations

Locations

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

Recruiting

Waterloo, Ontario, Canada, N2L 3G1

Contacts

Jill Woods

519 888 4567jwoods@uwaterloo.ca

Doerte Luensmann

519 888 4567doerte.luensmann@uwaterloo.ca

Principal Investigator:

Lyndon Jones, PhD

More Information

Sponsor

Myoptechs, Inc

Last update posted

Sep 4, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Myoptechs, Inc on 2025-09-04.