Evaluation of Comfort for Two Marketed Daily Disposable Contact Lenses

NCT ID: NCT04968925

Last Updated: 2022-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 302 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-12
• Study Completion Date: 2021-10-25

Brief Summary

This study is a 2-phase adaptive approach utilizing a 2×2 crossover design. The study lenses will be worn in a bilateral fashion for a period of approximately 1-week each.

Conditions

Visual Acuity

Study Design

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

Study Groups

O1D/P1

Eligible subjects that are habitual wearers of daily disposable soft contact lenses will randomly be assigned sequence (O1D/P1)

Group Type: EXPERIMENTAL

ACUVUE Oasys 1-Day

Intervention Type: DEVICE

TEST

Precision 1

Intervention Type: DEVICE

CONTROL

P1/O1D

Eligible subjects that are habitual wearers of daily disposable soft contact lenses will randomly be assigned sequence (P1/O1D)

Group Type: EXPERIMENTAL

ACUVUE Oasys 1-Day

Intervention Type: DEVICE

TEST

Precision 1

Intervention Type: DEVICE

CONTROL

Interventions

ACUVUE Oasys 1-Day

TEST

Intervention Type: DEVICE

Precision 1

CONTROL

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

4. By self-report, habitually wear soft spherical contact lenses in both eyes in a daily disposable wear modality. Habitual wear is defined as a minimum of 8 hours of wear per day, for a minimum of 4 days per week during the past 4 weeks.

5. By self-report, typically uses computer screens and other digital devices (phones, tablets) at least 30 hours per week.

6. The vertex-corrected best spherical distance refraction (rounded to nearest 0.25 D) must be between -1.00 and -4.00 DS (inclusive) in each eye.

7. The magnitude of the cylinder component of the subject's distance refraction must be 1.00 DC or less.

8. The subject must have best corrected visual acuity of 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 breastfeeding

2. 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. See Section 9.1 for additional details regarding excluded systemic medications.

3. Have had any previous ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, cataract, etc.).

4. Habitually wear monovision, multifocal, toric, or extended wear contact lens correction

5. Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment

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

7. Have a history of amblyopia or strabismus.

8. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (eg, SynergEyes) within the past 6 months.

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 any ocular infection.

• 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

James R. Dugue Optometry

Mission Viejo, California, United States

Maitland Vision Center

Maitland, Florida, United States

Flora Chen Poveda, OD, PA

Orange Park, Florida, United States

Visual Eyes, Inc

Roswell, Georgia, United States

VisionPoint Center

Bloomington, Illinois, United States

ABQ Eye Care

Albuquerque, New Mexico, United States

ProCare Vision Center

Granville, Ohio, United States

Optometry Group LLC

Memphis, Tennessee, United States

Gulf Coast Vision Center, Inc.

Houston, Texas, United States

Tyler Eye Associates

Tyler, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6456

Identifier Type: -

Identifier Source: org_study_id