Quantifying Ocular Surface Aberrations After Tear Film Interventions

NCT06966349 | Completed Phase 4 FDA Drug FDA Device

• 1 other identifier: 47100
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tear Film Characteristics

Outcome Measures

Primary Outcomes (3)

• Change in higher order aberrations with 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

  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

  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

Study Arms (2)

Experimental: Systane Complete / Senofilcon A/ Somofilcon A

EXPERIMENTAL

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; Device: Senofilcon A; Device: Somofilcon A

Experimental: Systane Complete/ Somofilcon A/ Senofilcon A

EXPERIMENTAL

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; Device: Senofilcon A; Device: Somofilcon A

Interventions

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.

Experimental: Systane Complete / Senofilcon A/ Somofilcon A; Experimental: Systane Complete/ Somofilcon A/ Senofilcon A

Senofilcon A DEVICE

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

Also known as: ACUVUE OASYS MAX 1-Day

Experimental: Systane Complete / Senofilcon A/ Somofilcon A; Experimental: Systane Complete/ Somofilcon A/ Senofilcon A

Somofilcon A DEVICE

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

Also known as: clariti 1 day

Experimental: Systane Complete / Senofilcon A/ Somofilcon A; Experimental: Systane Complete/ Somofilcon A/ Senofilcon A

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Waterloo: lead

Study Sites (1)

Centre for Ocular Research & Education

Waterloo, Ontario, N2L 3G1, Canada

Location

Study Officials

• Lyndon Jones, PhD, DSc, FCOptom

  Centre for Ocular Research & Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 11, 2025
• Study Start: June 10, 2025
• Primary Completion: January 29, 2026
• Study Completion: January 29, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)