Quantifying Ocular Surface Aberrations After Tear Film Interventions

Phase 4

Not yet recruiting

• Conditions: Tear Film Characteristics
• Interventions: Drug: Systane Complete Preservative-Free; Device: Senofilcon A; Device: Somofilcon A

• Registration Number: NCT06966349
• Lead Sponsor: University of Waterloo

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-02
• Study First Submitted QC: 2025-05-02
• Last Update Submitted: 2025-05-02
• Study First Posted: 2025-05-11
• Last Update Posted: 2025-05-11
• Study Start: 2025-06-01
• Primary Completion: 2025-08-29
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental: Systane Complete / Senofilcon A/ Somofilcon A	Systane Complete Preservative-Free	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.
Experimental: Systane Complete / Senofilcon A/ 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, senofilcon A will be worn in both eyes. On the third day of the study, somofilcon A will be worn in both eyes.
Experimental: Systane Complete / Senofilcon A/ Somofilcon 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.
Experimental: Systane Complete/ Somofilcon A/ Senofilcon A	Systane Complete Preservative-Free	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.
Experimental: Systane Complete/ Somofilcon A/ Senofilcon 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.
Experimental: Systane Complete/ Somofilcon A/ 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, somofilcon A will be worn in both eyes. On the third day of the study, senofilcon A will be worn in both eyes.

Primary Outcome Measures

Name	Time	Method
Change in higher order aberrations with an eye drop	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.
Change in higher order aberrations with senofilcon A	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.
Change in higher order aberrations with somofilcon A	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.