Evaluation of Comfort for Two Marketed Daily Disposable Contact Lenses

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Comfort for Two Marketed Daily Disposable Contact Lenses

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: ACUVUE Oasys 1-Day
* Device: Precision 1


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: O1D/P1<br>Eligible subjects that are habitual wearers of daily disposable soft contact lenses will randomly be assigned sequence (O1D/P1) | Device: ACUVUE Oasys 1-Day<br>* TEST<br>Device: Precision 1<br>* CONTROL<br>|
| Experimental: P1/O1D<br>Eligible subjects that are habitual wearers of daily disposable soft contact lenses will randomly be assigned sequence (P1/O1D) | Device: ACUVUE Oasys 1-Day<br>* TEST<br>Device: Precision 1<br>* CONTROL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort Throughout the Day (Phase II) | 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. | 1-Week Follow-up | 
| Comfort While Using Digital Devices (Phase II) | 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. | 1-Week Follow-up | 
| Dryness While Using Digital Devices (Phase II) | 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. | 1-Week Follow-up | 
| Lens Awareness Upon Insertion (Phase II) | 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. | 1-Minute Post lens fitting | 
| Comfort Upon Insertion (Phase II) | 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. | 1-Minute Post lens fitting | 
| Overall Ease of Handling (Phase II) | 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. | 1-Week Follow-up | 
| Ease of Insertion (Phase II) | 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. | 1-Week Follow-up | 
| Ease of Removal (Phase II) | 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. | 1-Week Follow-up |