Evaluation of ACUVUE OASYS® 1-Day for Astigmatism Lenses Produced on a New Manufacturing Line

NCT ID: NCT04794270

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-02
• Study Completion Date: 2021-04-13

Brief Summary

This is a bilateral, dispensing, randomized, controlled, double-masked, 2×2 cross-over study to evaluate the clinical performance of ACUVUE OASYS® 1-Day for Astigmatism contact lenses produced on a recently qualified manufacturing line.

Conditions

Visual Acuity

Study Design

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

Study Groups

TEST/CONTROL

Eligible subjects that are habitual contact lens wearers will be randomized into the (TEST/CONTROL) sequence and will wear two different study lenses one at a time over the two wear periods. During each wear period the lenses will be worn bilaterally for approximately 1 week. Study lenses will be worn for a minimum of 8 hours per day and at least 5 days per week during the wear period.

Group Type: EXPERIMENTAL

ACUVUE OASYS® 1-Day for Astigmatism - TAM 24

Intervention Type: DEVICE

TEST

ACUVUE OASYS® 1-Day for Astigmatism

Intervention Type: DEVICE

CONTROL

CONTROL/TEST

Eligible subjects that are habitual contact lens wearers will be randomized into the (CONTROL/TEST) sequence and will wear two different study lenses one at a time over the two wear periods. During each wear period the lenses will be worn bilaterally for approximately 1 week. Study lenses will be worn for a minimum of 8 hours per day and at least 5 days per week during the wear period.

Group Type: EXPERIMENTAL

ACUVUE OASYS® 1-Day for Astigmatism - TAM 24

Intervention Type: DEVICE

TEST

ACUVUE OASYS® 1-Day for Astigmatism

Intervention Type: DEVICE

CONTROL

Interventions

ACUVUE OASYS® 1-Day for Astigmatism - TAM 24

TEST

Intervention Type: DEVICE

ACUVUE OASYS® 1-Day for Astigmatism

CONTROL

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

The subject must:

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 39 (inclusive) years of age at the time of screening.

4. By self-report, habitually wear 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 2 days per week during the past month.

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

6. Have the spherical component of their vertex-corrected distance refraction must be between -0.875 to -4.625 DS (inclusive) in each eye.

7. Have the magnitude of the cylindrical component of their vertex-corrected distance refraction between 0.625 DC and 1.625 DC in both eyes.

8. Have the cylinder axis of their distance refraction between 165° and 15° (i.e., 180±15°, inclusive) or between 75° and 105° (i.e., 90±15°, inclusive) in each eye.

9. Have best corrected monocular distance visual acuity of 20/30 or better in each eye.

Exclusion Criteria

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

The subject must not:

1. Be currently pregnant or lactating.

2. Be diabetic.

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

4. 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.

5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.

6. Be currently wearing monovision or multifocal contact lenses.

7. Be currently wearing lenses in an extended wear modality.

8. Have a history of strabismus or amblyopia.

9. 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.

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

11. 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).

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

13. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 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

Sabal Eye Care

Longwood, Florida, United States

VisionPoint Eye Center

Bloomington, Illinois, United States

Kannarr Eye Care

Pittsburg, Kansas, United States

Sacco Eye Group

Vestal, New York, United States

Professional Vision Care, Inc.

Westerville, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6420

Identifier Type: -

Identifier Source: org_study_id