CompletedPhase 4

Quantifying Ocular Surface Aberrations After Tear Film Interventions

Canada10 participantsStarted 2025-06-10

Plain-language summary

The CA-800 Corneal Analyzer (Visia Imaging S.R.L., Italy) is a device that can measure small imperfections in the tear film when the eyes are open. The goal of this study is to see if the device can detect changes in the tear film after instillation of an eye drop or when contact lenses are worn.

Who can participate

Age range17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Are at least 17 years of age and have full legal capacity to volunteer.
✓. Have signed the information consent letter.
✓. Are willing and able to follow instructions and maintain the appointment schedule.
✓. Habitually wear spherical soft contact lenses (no multifocal lens, no toric lens wear or extended (overnight) wear).
✓. Have a vertex-corrected refractive astigmatism of no more than 0.75D in each eye.
✓. Achieve a best corrected visual acuity of 0.00 logMAR or better in each eye.
✓. Agree to wear the study contact lenses for at least 6 hours.
✓. Have clear corneas (e.g. no central scars).

Exclusion criteria

✕. Are participating in another concurrent clinical research study.
✕. Have worn any rigid contact lenses in the past 30 days.
✕. Have been diagnosed with irregular cornea (e.g., keratoconus, etc.).
✕. Have any known active ocular condition, disease, and/or infection.\*
✕. Have a systemic or ocular condition that, in the opinion of the investigator, may affect a study outcome variable.

What they're measuring

Change in higher order aberrations with an eye drop

Timeframe: Baseline (prior to instillation); immediately, 10, 20, 30, and 60 minutes post instillation of an eye drop

Change in higher order aberrations with senofilcon A

Timeframe: Baseline (prior to insertion); immediately, 30 minutes, and 6 hours post insertion of a contact lens

Change in higher order aberrations with somofilcon A

Timeframe: Baseline (prior to insertion); immediately, 30 minutes, and 6 hours post insertion of a contact lens

Trial details

NCT IDNCT06966349

SponsorUniversity of Waterloo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-29

View on ClinicalTrials.gov More Tear Film Characteristics trials

Who can participate

Age range17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Are at least 17 years of age and have full legal capacity to volunteer.
✓. Have signed the information consent letter.
✓. Are willing and able to follow instructions and maintain the appointment schedule.
✓. Habitually wear spherical soft contact lenses (no multifocal lens, no toric lens wear or extended (overnight) wear).
✓. Have a vertex-corrected refractive astigmatism of no more than 0.75D in each eye.
✓. Achieve a best corrected visual acuity of 0.00 logMAR or better in each eye.
✓. Agree to wear the study contact lenses for at least 6 hours.
✓. Have clear corneas (e.g. no central scars).

Exclusion criteria

✕. Are participating in another concurrent clinical research study.
✕. Have worn any rigid contact lenses in the past 30 days.
✕. Have been diagnosed with irregular cornea (e.g., keratoconus, etc.).
✕. Have any known active ocular condition, disease, and/or infection.\*
✕. Have a systemic or ocular condition that, in the opinion of the investigator, may affect a study outcome variable.

What they're measuring

Change in higher order aberrations with an eye drop

Timeframe: Baseline (prior to instillation); immediately, 10, 20, 30, and 60 minutes post instillation of an eye drop

Change in higher order aberrations with senofilcon A

Timeframe: Baseline (prior to insertion); immediately, 30 minutes, and 6 hours post insertion of a contact lens

Change in higher order aberrations with somofilcon A

Timeframe: Baseline (prior to insertion); immediately, 30 minutes, and 6 hours post insertion of a contact lens