Visual Performance of Senofilcon A With and Without a New UV/HEV-filter

NCT ID: NCT05021081

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-23
• Study Completion Date: 2021-10-20

Brief Summary

This study will occur in two non-dispensing phases: Phase 1 is a non-randomized, non-masked, non-dispensing study where subjects will wear their own contact lenses for approximately 1 hour. Phase 2 is a controlled, randomized, double-masked, contralateral non-dispensing study where the study lenses will be worn in a daily wear modality for approximately 3 hours.

Conditions

Visual Performance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TEST/CONTROL

For Phase 2, eligible subjects that are enrolled will be randomized to the Test/Control contralateral sequence.

Group Type: EXPERIMENTAL

TRP-200

Intervention Type: DEVICE

JJVC Investigational Contact Lens

ACUVUE Oasys 1-Day

Intervention Type: DEVICE

JJVC Marketed Contact Lens

CONTROL/TEST

For Phase 2, eligible subjects that are enrolled will be randomized to the Control/Test contralateral sequence.

Group Type: EXPERIMENTAL

TRP-200

Intervention Type: DEVICE

JJVC Investigational Contact Lens

ACUVUE Oasys 1-Day

Intervention Type: DEVICE

JJVC Marketed Contact Lens

Interventions

TRP-200

JJVC Investigational Contact Lens

Intervention Type: DEVICE

ACUVUE Oasys 1-Day

JJVC Marketed Contact Lens

Intervention Type: DEVICE

Other Intervention Names

TEST; CONTROL

Eligibility Criteria

Inclusion 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. For Phase I be between 18-39 (inclusive) years of age at the time of screening.

4. For Phase II be between 18 and 70 (inclusive) years of age at the time of screening.

5. By self-report, habitually wear spherical 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 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.

6. Possess a wearable pair of spectacles that provide correction for distance vision.

7. Habitual spherical contact lens powers must be between -1.00 D and -6.00 D (inclusive) in each eye.

8. For Phase I, habitual contact lenses must provide at least 20/20 acuity OD and OS.

9. For Phase II, the spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 D and -6.00 D (inclusive) in each eye.

10. For Phase II, the magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be between 0.00 D and 1.00 D (inclusive) in each eye.

11. For Phase II, the best corrected, monocular, distance visual acuity must be 20/25 or better in each eye.

Exclusion Criteria

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

1. Be currently pregnant or lactating.

2. Be currently using any ocular medications or have any ocular infection of any type.

3. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures.

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 lenses in an extended wear modality.

7. Have participated in a contact lens or lens care product clinical trial within 30 days prior to study enrollment.

8. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.

9. Have clinically significant (grade 3 or higher on the FDA 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 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).

10. Have a history of strabismus or amblyopia.

11. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.

12. Have had any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

13. Have signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar).

14. Have a history of eyelid injury, surgery or procedure that resulted in abnormal eyelid position or movement.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 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

University of Georgia

Athens, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6463

Identifier Type: -

Identifier Source: org_study_id