Evaluation of Comfort for Two Marketed Daily Disposable Contact Lenses

Not Applicable

Completed

Conditions: Visual Acuity

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

Registration Number: NCT04968925

Lead Sponsor: Johnson & Johnson Vision Care, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 302

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
O1D/P1	Precision 1	Eligible subjects that are habitual wearers of daily disposable soft contact lenses will randomly be assigned sequence (O1D/P1)
P1/O1D	ACUVUE Oasys 1-Day	Eligible subjects that are habitual wearers of daily disposable soft contact lenses will randomly be assigned sequence (P1/O1D)
P1/O1D	Precision 1	Eligible subjects that are habitual wearers of daily disposable soft contact lenses will randomly be assigned sequence (P1/O1D)
O1D/P1	ACUVUE Oasys 1-Day	Eligible subjects that are habitual wearers of daily disposable soft contact lenses will randomly be assigned sequence (O1D/P1)

Primary Outcome Measures

Name	Time	Method
Overall Comfort (Phase I)	1-Week Follow-up	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.
End of Day Comfort (Phase I)	1-Week Follow-up	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.
End of Day Dryness (Phase I)	1-Week Follow-up	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.
End of Day Dryness (Phase II)	1-Week Follow-up	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.
Overall Comfort (Phase II)	1-Week Follow-up	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.
End of Day Comfort (Phase II)	1-Week Follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Comfort While Using Digital Devices (Phase II)	1-Week Follow-up	Comfort while Using Digital Devices was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Remaining comfortable while using computer screens and other digital devices (phones, tablets)" with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Lens Awareness Upon Insertion (Phase II)	1-Minute Post lens fitting	Lens Awareness Upon Insertion was assessed using the individual questionnaire item "I lost awareness of these lenses shortly after inserting them (within one minute)" with a 5-point Agreement Response Set of 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Subject responses are reported by lens using frequencies.
Comfort Upon Insertion (Phase II)	1-Minute Post lens fitting	Comfort Upon Insertion was assessed using the individual questionnaire item "These lenses were comfortable shortly after inserting them (within one minute)" with a 5-point Agreement Response Set of 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Subject responses are reported by lens using frequencies.
Comfort Throughout the Day (Phase II)	1-Week Follow-up	Comfort Throughout the Day was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes feeling comfortable from morning to night" 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.
Ease of Removal (Phase II)	1-Week Follow-up	Ease of Removal was assessed using the individual questionnaire item "how would you rate the study contact lenses on: Ease of taking the lenses off your eyes" with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Dryness While Using Digital Devices (Phase II)	1-Week Follow-up	Dryness while using Digital Devices was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry while using computer screens and other digital devices (phones, tablets)." with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Overall Ease of Handling (Phase II)	1-Week Follow-up	Overall Ease of Handling was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall ease of handling the lenses (putting them on and taking them off)." with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Ease of Insertion (Phase II)	1-Week Follow-up	Ease of Insertion was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Ease of putting the lenses on your eyes " with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.

Trial Locations

Locations (10): 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
James R. Dugue Optometry
🇺🇸Mission Viejo, California, United States