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RecruitingPhase 4NCT06966349

Quantifying Ocular Surface Aberrations After Tear Film Interventions

Sponsor

University of Waterloo

Enrollment

12 participants

Start Date

Jun 10, 2025

Study Type

INTERVENTIONAL

Conditions

Tear Film Characteristics

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.

Eligibility

Min Age: 17 Years

Inclusion Criteria9

  • 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).
  • Have no active ocular disease or inflammation.

Exclusion Criteria8

  • 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.
  • Have a known sensitivity to the diagnostic sodium fluorescein to be used in the study.
  • Have undergone refractive error surgery.
  • Are a member of the study team for this study, i.e. are listed on the delegation log for this study.

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Interventions

DRUGSystane Complete Preservative-Free

One drop of Systane Complete Preservative Free will be instilled in each eye. Higher order aberrations assessed before and after instillation.

DEVICESenofilcon A

Daily disposable silicone hydrogel contact lenses indicated for myopia or hyperopia. Higher order aberrations assessed before and after instillation.

DEVICESomofilcon A

Daily disposable silicone hydrogel contact lenses indicated for myopia or hyperopia. Higher order aberrations assessed before and after instillation.

Locations(1)

Centre for Ocular Research & Education

Waterloo, Ontario, Canada

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NCT06966349