Clinical Performance of Three Daily Disposable Silicone Hydrogel Contact Lenses

Johnson & Johnson (J&J)

Status: Completed

Conditions: Visual Acuity

Treatments: Device: Test Lens 3; Device: Test Lens 2; Device: Test Lens 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT06778057

CR-6595

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Be between 18 and 40 (inclusive) years of age at the time of screening.
4. By self-report, they typically use digital devices for a minimum of 4 hours per day, 5 days per week.
5. In a pre-study screening assessment, they must have a CVS-Q score of 6 or greater.
6. Agree not to participate in other clinical research while enrolled on this study.
7. Own a wearable pair of spectacles, if needed, for distance vision correction (by self-report).
8. By self-report, habitually wear silicone hydrogel soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 8 hours of wear per day, for at least 4 days per week over the past 4 weeks.
9. Attain a best-corrected logMAR distance visual acuity of at least 0.20 in each eye.
10. Have spherical contact lens prescription in the range -1.00 to -6.00 DS (based on the calculated ocular refraction) in each eye.
11. Have up to a maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction) in each eye.

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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22 participants in 6 patient groups

Test Lens 1/Test Lens 2/Test Lens 3

Experimental group

Description:

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.

Treatment:

Device: Test Lens 1

Device: Test Lens 2

Device: Test Lens 3

Test Lens 1/Test Lens 3/Test Lens 2

Experimental group

Description:

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.

Treatment:

Device: Test Lens 1

Device: Test Lens 2

Device: Test Lens 3

Test Lens 2/Test Lens 1/Test Lens 3

Experimental group

Description:

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.

Treatment:

Device: Test Lens 1

Device: Test Lens 2

Device: Test Lens 3

Test Lens 2/Test Lens 3/Test Lens 1

Experimental group

Description:

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.

Treatment:

Device: Test Lens 1

Device: Test Lens 2

Device: Test Lens 3

Test Lens 3/Test Lens 1/Test Lens 2

Experimental group

Description:

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.

Treatment:

Device: Test Lens 1

Device: Test Lens 2

Device: Test Lens 3

Test Lens 3/Test Lens 2/Test Lens 1

Experimental group

Description:

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.

Treatment:

Device: Test Lens 1

Device: Test Lens 2

Device: Test Lens 3