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Completed

NCT Number: NCT06966349

Quantifying Ocular Surface Aberrations After Tear Film Interventions

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.

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Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre for Ocular Research & Education

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).
  • Have no active ocular disease or inflammation.

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.
  • 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.

Treatment and study plan

Systane Complete Preservative-Free

Drug

One drop of Systane Complete Preservative Free will be instilled in each eye.

Higher order aberrations assessed before and after instillation.

Senofilcon A

Device

Daily disposable silicone hydrogel contact lenses indicated for myopia or hyperopia.

Higher order aberrations assessed before and after instillation.

Other names: ACUVUE OASYS MAX 1-Day

somofilcon A

Device

Daily disposable silicone hydrogel contact lenses indicated for myopia or hyperopia.

Higher order aberrations assessed before and after instillation.

Other names: clariti 1 day

Primary outcomes

  1. Change in higher order aberrations with an eye drop

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

    The change in root mean square (measured in microns) was assessed over 20 seconds. Data from the right eye was analyzed.

  2. Change in higher order aberrations with senofilcon A

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

    The change in root mean square (measured in microns) was assessed over 20 seconds. Data from the right eye was analyzed.

  3. Change in higher order aberrations with somofilcon A

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

    The change in root mean square (measured in microns) was assessed over 20 seconds. Data from the right eye was analyzed.

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Registry information

Acronym: GAMBIA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 11, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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