Quantifying Ocular Surface Aberrations After Tear Film Interventions (GAMBIA)

April 23, 2026 updated by: University of Waterloo
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Waterloo, Ontario, Canada, N2L 3G1
        • Centre for Ocular Research & Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Are participating in another concurrent clinical research study.
  2. Have worn any rigid contact lenses in the past 30 days.
  3. Have been diagnosed with irregular cornea (e.g., keratoconus, etc.).
  4. Have any known active ocular condition, disease, and/or infection.*
  5. Have a systemic or ocular condition that, in the opinion of the investigator, may affect a study outcome variable.
  6. Have a known sensitivity to the diagnostic sodium fluorescein to be used in the study.
  7. Have undergone refractive error surgery.
  8. Are a member of the study team for this study, i.e. are listed on the delegation log for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Systane Complete / Senofilcon A/ Somofilcon A
On the first day of the study, one drop of Systane Complete will be instilled in each eye. On the second day of the study, senofilcon A will be worn in both eyes. On the third day of the study, somofilcon A will be worn in both eyes.
Drug: Systane Complete Preservative-Free

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

Higher order aberrations assessed before and after instillation.

Device: Senofilcon A

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
Device: Somofilcon A

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

Higher order aberrations assessed before and after instillation.

Other Names:
  • clariti 1 day
Experimental: Experimental: Systane Complete/ Somofilcon A/ Senofilcon A
On the first day of the study, one drop of Systane Complete will be instilled in each eye. On the second day of the study, somofilcon A will be worn in both eyes. On the third day of the study, senofilcon A will be worn in both eyes.
Drug: Systane Complete Preservative-Free

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

Higher order aberrations assessed before and after instillation.

Device: Senofilcon A

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
Device: Somofilcon A

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

Higher order aberrations assessed before and after instillation.

Other Names:
  • clariti 1 day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Baseline (prior to insertion); immediately, 30 minutes, and 6 hours post insertion of a contact lens
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.
Baseline (prior to insertion); immediately, 30 minutes, and 6 hours post insertion of a contact lens

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Waterloo

Investigators

  • Principal Investigator: Lyndon Jones, PhD, DSc, FCOptom, Centre for Ocular Research & Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2025

Primary Completion (Actual)

January 29, 2026

Study Completion (Actual)

January 29, 2026

Study Registration Dates

First Submitted

May 2, 2025

First Submitted That Met QC Criteria

May 2, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 47100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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