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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-25

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Myopia; Refractive Error

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lens A

Group Type EXPERIMENTAL

Lens A

Intervention Type DEVICE

Lens A of Study P/883/24/MO

Lens B

Intervention Type DEVICE

Lens B of Study P/883/24/MO

Lens C

Intervention Type DEVICE

Lens C of Study P/883/24/MO

Lens B

Group Type EXPERIMENTAL

Lens A

Intervention Type DEVICE

Lens A of Study P/883/24/MO

Lens B

Intervention Type DEVICE

Lens B of Study P/883/24/MO

Lens C

Intervention Type DEVICE

Lens C of Study P/883/24/MO

Lens C

Group Type EXPERIMENTAL

Lens A

Intervention Type DEVICE

Lens A of Study P/883/24/MO

Lens B

Intervention Type DEVICE

Lens B of Study P/883/24/MO

Lens C

Intervention Type DEVICE

Lens C of Study P/883/24/MO

Interventions

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Lens A

Lens A of Study P/883/24/MO

Intervention Type DEVICE

Lens B

Lens B of Study P/883/24/MO

Intervention Type DEVICE

Lens C

Lens C of Study P/883/24/MO

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No