Evaluation of Comfort for Two Marketed Daily Disposable Contact Lenses

NCT04968925 | Completed Results FDA Device

• 1 other identifier: CR-6456
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 10

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

Outcome Measures

Primary Outcomes (6)

• Overall Comfort (Phase I)

  Overall Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall Comfort" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.

  1-Week Follow-up

• End of Day Comfort (Phase I)

  End of day Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: comfort at the end of the day" with aa 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.

  1-Week Follow-up

• End of Day Dryness (Phase I)

  End of day Dryness was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.

  1-Week Follow-up

• End of Day Comfort (Phase II)

  End of day Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: comfort at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.

  1-Week Follow-up

• End of Day Dryness (Phase II)

  End of day Dryness was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.

  1-Week Follow-up

• Overall Comfort (Phase II)

  Overall Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall Comfort" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.

  1-Week Follow-up

Secondary Outcomes (8)

• Comfort Throughout the Day (Phase II)

  1-Week Follow-up

• Comfort While Using Digital Devices (Phase II)

  1-Week Follow-up

• Dryness While Using Digital Devices (Phase II)

  1-Week Follow-up

• Lens Awareness Upon Insertion (Phase II)

  1-Minute Post lens fitting

• Comfort Upon Insertion (Phase II)

  1-Minute Post lens fitting

Study Arms (2)

O1D/P1

EXPERIMENTAL

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

Device: ACUVUE Oasys 1-Day; Device: Precision 1

P1/O1D

EXPERIMENTAL

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

Device: ACUVUE Oasys 1-Day; Device: Precision 1

Interventions

ACUVUE Oasys 1-Day DEVICE

TEST

O1D/P1; P1/O1D

Precision 1 DEVICE

CONTROL

O1D/P1; P1/O1D

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:
• Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• Appear able and willing to adhere to the instructions set forth in this clinical protocol.
• Be between 18 and 40 (inclusive) years of age at the time of screening.
• 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.
• By self-report, typically uses computer screens and other digital devices (phones, tablets) at least 30 hours per week.
• 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.
• The magnitude of the cylinder component of the subject's distance refraction must be 1.00 DC or less.
• The subject must have best corrected visual acuity of 20/25 or better in each eye.

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• Be currently pregnant or breastfeeding
• 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.
• Have had any previous ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, cataract, etc.).
• Habitually wear monovision, multifocal, toric, or extended wear contact lens correction
• Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment
• Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
• Have a history of amblyopia or strabismus.
• Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (eg, SynergEyes) within the past 6 months.
• 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).
• Have any ocular infection.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (10)

James R. Dugue Optometry

Mission Viejo, California, 92691, United States

Location

Maitland Vision Center

Maitland, Florida, 32751, United States

Location

Flora Chen Poveda, OD, PA

Orange Park, Florida, 32073, United States

Location

Visual Eyes, Inc

Roswell, Georgia, 30076, United States

Location

VisionPoint Center

Bloomington, Illinois, 61704, United States

Location

ABQ Eye Care

Albuquerque, New Mexico, 87109, United States

Location

ProCare Vision Center

Granville, Ohio, 43023, United States

Location

Optometry Group LLC

Memphis, Tennessee, 38111, United States

Location

Gulf Coast Vision Center, Inc.

Houston, Texas, 77054, United States

Location

Tyler Eye Associates

Tyler, Texas, 75703, United States

Location

Results Point of Contact

• Title: Ross Franklin, BAppSc-Optom
• Organization: Johnson & Johnson Vision Care, Inc. (JJVC)

RFRANKL1@its.jnj.com

1-800-843-2020

Study Officials

• Johnson & Johnson Vision Care, Inc. Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 20, 2021
• Study Start: July 12, 2021
• Primary Completion: October 25, 2021
• Study Completion: October 25, 2021
• Last Updated: December 22, 2022
• Results First Posted: December 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

US (10)