Evaluation of ACUVUE® OASYS 1-Day for Astigmatism Contact Lenses With Alternative Lidstock

NCT ID: NCT05713552

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2023-02-09

Brief Summary

This will be a single-visit, randomized, double-masked, bilateral wear, non-dispensing, 2-sequence × 2-period crossover study to evaluate subject reported ocular symptoms.

Conditions

Ocular Physiology

Study Design

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

Study Groups

Test/Control

Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to wear two different study lenses, one at a time, over two wear periods (test then control) with a washout period of 15 minutes between wears. During each wear period the lenses will be worn bilaterally for at least one hour in-office.

Group Type: EXPERIMENTAL

Acuvue Oasys 1 Day for Astigmatism with Legacy lidstock

Intervention Type: DEVICE

CONTROL

Acuvue Oasys 1 Day for Astigmatism with Amcor laminated lidstock

Intervention Type: DEVICE

TEST

Control/Test

Eligible subjects who are habitual soft contact lens wearers will be randomized into the Control/Test sequence, to wear two different study lenses, one at a time, over two wear periods (control then test) with a washout period of 15 minutes between wears. During each wear period the lenses will be worn bilaterally for at least one hour in-office.

Group Type: EXPERIMENTAL

Acuvue Oasys 1 Day for Astigmatism with Legacy lidstock

Intervention Type: DEVICE

CONTROL

Acuvue Oasys 1 Day for Astigmatism with Amcor laminated lidstock

Intervention Type: DEVICE

TEST

Interventions

Acuvue Oasys 1 Day for Astigmatism with Legacy lidstock

CONTROL

Intervention Type: DEVICE

Acuvue Oasys 1 Day for Astigmatism with Amcor laminated lidstock

TEST

Intervention Type: DEVICE

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. Be between 18 and 39 years of age (inclusive) at the time of screening.

4. Habitually wear soft contact lenses (either sphere or toric) 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 per day, for a minimum of 2 days per week during the past four weeks.

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

6. Have the spherical component of their vertex-corrected distance refraction within the range +4.00 to -9.00 DS (inclusive) in both eyes.

7. Have the magnitude of the cylindrical component of their vertex-corrected distance refraction below 3.00 DC (inclusive) in both eyes.

8. Have best corrected monocular distance VA 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 an ocular infection of any type.

4. Have any ocular or systemic allergies, disease, infection, or use of medication that might contraindicate or interfere with contact lens wear or otherwise compromise study endpoints, including infectious diseases (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), or history of serious mental illness or seizures. See section 9.1 for additional details regarding systemic medications.

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 or be currently wearing lenses in an extended wear modality.

7. Have a history of strabismus or amblyopia.

8. Be an employee (e.g., Investigator, Coordinator, Technician) or family member of an employee of investigational clinic.

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

10. Have clinically significant (Grade 3 or 4 on the FDA classification 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 may contraindicate contact lens wear or otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).

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

12. Have had or have planned (within the study period) ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, 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

VRC

Jacksonville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6530

Identifier Type: -

Identifier Source: org_study_id