Clinical Performance of Two Daily Disposable Silicone Hydrogel Contact Lenses

NCT ID: NCT05554640

Last Updated: 2023-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-24
• Study Completion Date: 2022-12-01

Brief Summary

This is a subject-masked, randomized, bilateral, 2x2 crossover clinical investigation that will assess lens fit acceptance.

Conditions

Visual Acuity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test/Control

Eligible subjects that are habitual contact lens wearers will be randomized into the sequence, Test/Control.

Group Type: EXPERIMENTAL

Acuvue® Oasys MAX 1-Day

Intervention Type: DEVICE

TEST Lens

Dailies Total 1

Intervention Type: DEVICE

CONTROL Lens

Control/Test

Eligible subjects that are habitual contact lens wearers will be randomized into the sequence, Test/Control.

Group Type: EXPERIMENTAL

Acuvue® Oasys MAX 1-Day

Intervention Type: DEVICE

TEST Lens

Dailies Total 1

Intervention Type: DEVICE

CONTROL Lens

Interventions

Acuvue® Oasys MAX 1-Day

TEST Lens

Intervention Type: DEVICE

Dailies Total 1

CONTROL Lens

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

1. The subject must 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. Between 18 and 40 (inclusive) years of age at the time of screening.

4. They agree not to participate in other clinical research while enrolled on this study.

5. They have worn the same brand of soft daily disposable silicone hydrogel contact lenses at least eight hours per day for at least four days per week over the past 4 weeks.

6. They own a wearable pair of spectacles if needed for distance vision correction (by self-report).

7. They can attain a best-corrected logMAR distance visual acuity of at least 0.20 in each eye.

8. They have spherical contact lens prescription in the range -1.00 to -6.00 DS (based on the calculated ocular refraction).

9. They have up to maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction).

Exclusion Criteria

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

1. Currently pregnant or lactating.

2. 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, by self-report, which are known to interfere with contact lens wear and/or participation in the study or may pose a risk to study personnel.

3. They have an ocular disorder which would normally contraindicate contact lens wear.

4. They have had cataract surgery.

5. They have had corneal refractive surgery.

6. They are using any topical medications such as eye drops or ointments.

7. Any known hypersensitivity or allergic reaction to sodium fluorescein.

8. 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.

9. Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.

10. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).

11. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

12. Any Efron Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection), 13. They have a pre-corneal tear film break-up time less than five seconds when evaluated on the DESMD tear film imaging system.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Vision Care, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Vision Care, Inc.

Locations

The University of Manchester

Manchester, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6495

Identifier Type: -

Identifier Source: org_study_id