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Clinical Performance of Three Daily Disposable Silicone Hydrogel Contact Lenses

NCT ID: NCT06778057

Last Updated: 2025-12-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-29

Study Completion Date

2025-10-16

Brief Summary

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This is a subject-masked, randomized, prospective, bilateral, 3x3 crossover dispensing clinical investigation to assess the clinical performance of a new lens type comparison.

Detailed Description

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Conditions

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Visual Acuity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Test Lens 3/Test Lens 2/Test Lens 1

Eligible subjects will be randomized into the Test Lens 3/Test Lens 2/Test Lens 1 sequence, to wear each lens for up to 10 hours each.

Group Type EXPERIMENTAL

Test Lens 1

Intervention Type DEVICE

Acuvue® Oasys MAX 1-Day daily disposable contact lenses

Test Lens 2

Intervention Type DEVICE

Dailies Total 1 daily disposable contact lenses

Test Lens 3

Intervention Type DEVICE

Clariti 1-Day daily disposable contact lenses

Test Lens 1/Test Lens 2/Test Lens 3

Eligible subjects will be randomized into the Test Lens 1/Test Lens 2/Test Lens 3 sequence, to wear each lens for up to 10 hours each.

Group Type EXPERIMENTAL

Test Lens 1

Intervention Type DEVICE

Acuvue® Oasys MAX 1-Day daily disposable contact lenses

Test Lens 2

Intervention Type DEVICE

Dailies Total 1 daily disposable contact lenses

Test Lens 3

Intervention Type DEVICE

Clariti 1-Day daily disposable contact lenses

Test Lens 1/Test Lens 3/Test Lens 2

Eligible subjects will be randomized into the Test Lens 1/Test Lens 3/Test Lens 2 sequence, to wear each lens for up to 10 hours each.

Group Type EXPERIMENTAL

Test Lens 1

Intervention Type DEVICE

Acuvue® Oasys MAX 1-Day daily disposable contact lenses

Test Lens 2

Intervention Type DEVICE

Dailies Total 1 daily disposable contact lenses

Test Lens 3

Intervention Type DEVICE

Clariti 1-Day daily disposable contact lenses

Test Lens 2/Test Lens 1/Test Lens 3

Eligible subjects will be randomized into the Test Lens 2/Test Lens 1/Test Lens 3 sequence, to wear each lens for up to 10 hours each.

Group Type EXPERIMENTAL

Test Lens 1

Intervention Type DEVICE

Acuvue® Oasys MAX 1-Day daily disposable contact lenses

Test Lens 2

Intervention Type DEVICE

Dailies Total 1 daily disposable contact lenses

Test Lens 3

Intervention Type DEVICE

Clariti 1-Day daily disposable contact lenses

Test Lens 2/Test Lens 3/Test Lens 1

Eligible subjects will be randomized into the Test Lens 2/Test Lens 3/Test Lens 1 sequence, to wear each lens for up to 10 hours each.

Group Type EXPERIMENTAL

Test Lens 1

Intervention Type DEVICE

Acuvue® Oasys MAX 1-Day daily disposable contact lenses

Test Lens 2

Intervention Type DEVICE

Dailies Total 1 daily disposable contact lenses

Test Lens 3

Intervention Type DEVICE

Clariti 1-Day daily disposable contact lenses

Test Lens 3/Test Lens 1/Test Lens 2

Eligible subjects will be randomized into the Test Lens 3/Test Lens 1/Test Lens 2 sequence, to wear each lens for up to 10 hours each.

Group Type EXPERIMENTAL

Test Lens 1

Intervention Type DEVICE

Acuvue® Oasys MAX 1-Day daily disposable contact lenses

Test Lens 2

Intervention Type DEVICE

Dailies Total 1 daily disposable contact lenses

Test Lens 3

Intervention Type DEVICE

Clariti 1-Day daily disposable contact lenses

Interventions

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Test Lens 1

Acuvue® Oasys MAX 1-Day daily disposable contact lenses

Intervention Type DEVICE

Test Lens 2

Dailies Total 1 daily disposable contact lenses

Intervention Type DEVICE

Test Lens 3

Clariti 1-Day daily disposable contact lenses

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

1. Be currently pregnant or lactating.
2. By self-report, have any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g. hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g., rheumatoid arthritis), or other diseases, which in the opinion of the investigator is likely to interfere with contact lens wear and/or participation in the study or may pose a risk to study personnel.
3. Have an ocular disorder which would normally contraindicate contact lens wear.
4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
5. Be currently wearing monovision or multifocal contact lenses.
6. Be currently wearing or have had worn Acuvue® Oasys 1-Day, Dailies® Total1, or Clariti 1-Day lenses during the last 3 months.
7. Have had cataract surgery.
8. Have had corneal refractive surgery.
9. Be using any topical medications such as eye drops or ointments.
10. Have a known hypersensitivity or allergic reaction to sodium fluorescein.
11. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear. See section 9.1 for additional details regarding excluded systemic medications.
12. Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrolment
13. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
14. Have clinically significant (grade 3 or higher on the Efron grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that in the opinion of the investigator would contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
15. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
16. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Vision Care, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Vision Care, Inc.

Locations

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The University of Manchester, Department of Optometry & Neuroscience

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CR-6595

Identifier Type: -

Identifier Source: org_study_id