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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorMyoptechs, Inc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

20 Participants
are divided into 3 treatment groups
Group A: Lens AExperimental treatment 3 interventions
Group B: Lens BExperimental treatment 3 interventions
Group C: Lens CExperimental treatment 3 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Myoptechs, Inc

Lead sponsor

University of Waterloo School of Optometry and Vision Science

Collaborator