Quantifying Ocular Surface Aberrations After Tear Film Interventions

NCT ID: NCT06966349

Last Updated: 2025-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-10

Study Completion Date

2025-12-15

Brief Summary

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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

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Conditions

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Tear Film Characteristics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Systane Complete Preservative-Free

Intervention Type DRUG

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

Higher order aberrations assessed before and after instillation.

Senofilcon A

Intervention Type DEVICE

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

Higher order aberrations assessed before and after instillation.

Somofilcon A

Intervention Type DEVICE

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

Higher order aberrations assessed before and after instillation.

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.

Group Type EXPERIMENTAL

Systane Complete Preservative-Free

Intervention Type DRUG

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

Higher order aberrations assessed before and after instillation.

Senofilcon A

Intervention Type DEVICE

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

Higher order aberrations assessed before and after instillation.

Somofilcon A

Intervention Type DEVICE

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

Higher order aberrations assessed before and after instillation.

Interventions

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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.

Intervention Type DRUG

Senofilcon A

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

Higher order aberrations assessed before and after instillation.

Intervention Type DEVICE

Somofilcon A

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

Higher order aberrations assessed before and after instillation.

Intervention Type DEVICE

Other Intervention Names

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ACUVUE OASYS MAX 1-Day clariti 1 day

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Waterloo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lyndon Jones, PhD, DSc, FCOptom

Role: PRINCIPAL_INVESTIGATOR

Centre for Ocular Research & Education

Locations

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Centre for Ocular Research & Education

Waterloo, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jill Woods, MSc, MCOptom

Role: CONTACT

519-888-4567 ext. 36743

Lyndon Jones, PhD, DSc, FCOptom

Role: CONTACT

519-888-4567 ext. 35030

Facility Contacts

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Jill Woods, MSc, MCOptom

Role: primary

519-888-4567 ext. 46743

Other Identifiers

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47100

Identifier Type: -

Identifier Source: org_study_id

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