Evaluation of Three Daily Disposable Contact Lenses

Study Overview
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Brief Summary
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This is a single-site, 8-visit, double-masked, cross-over study involving three marketed products as study lenses. Participants will be randomly assigned each lens type, which will be worn for approximately two weeks (12 +/- 2 days) each. Participants will undergo a minimum washout period of 3 days before entering the study and undergo a minimum 7 day washout period between dispensing each lens type.

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: Lens 1 (etafilcon A)
* Device: Lens 2 (nelfilcon A)
* Device: Lens 3 (nesofilcon A)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form; The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol; The subject must be willing and able to follow instructions and maintain the appointment schedule; The subject must be between the age of 18 and 40 years (inclusive); The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 Diopters (D) to -6.00 D in each eye (inclusive); The subject's refractive cylinder must not exceed -1.25 Diopters of Cylinder (DC) in each eye after vertexing to the corneal plane; The subject must have best corrected visual acuity of 0.2 Logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye; The subject must be a current wearer of spherical, soft contact lenses (no toric, bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment; The subject must own a wearable pair of spectacles and wear them the day of the initial visit; The subject must be an existing wearer of spherical, soft contact lenses in both eyes; The subject must have normal eyes (i.e., no ocular medications or infections of any type); The subject must be willing to wear the study lenses for a minimum eight hours per day. Exclusion Criteria: Any ocular or systemic allergies or diseases that may interfere with contact lens wear (at the investigator's discretion); Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion); Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued); Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease; Any active ocular infection; Is using any topical medications (excluding artificial tears (ATS)) up to two weeks prior to the screening visit; Any participants whose habitual contact lenses are used as an extended wear regimen; Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry; Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.); Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear; or clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear; Any known hypersensitivity or allergic reaction to the study products; Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment; Employee or family member of the Centre for Contact Lens Research (e.g., Investigator, Coordinator, Technician).

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lens 1/ Lens 2/ Lens 3<br>Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 1 (etafilcon A), then wear Lens 2 (nelfilcon A) second and then wear Lens 3 (nesofilcon A) third. | Device: Lens 1 (etafilcon A)<br>* Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).<br>* Other names: 1-Day Acuvue® Moist®;Device: Lens 2 (nelfilcon A)<br>* Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).<br>* Other names: Dailies® AquaComfort Plus®;Device: Lens 3 (nesofilcon A)<br>* Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).<br>* Other names: Biotrue ONEday;|
| Active Comparator: Lens 1 / Lens 3 / Lens 2<br>Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 1 (etafilcon A), then wear Lens 3 (nesofilcon A) second and then wear Lens 2 (nelfilcon A) third. | Device: Lens 1 (etafilcon A)<br>* Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).<br>* Other names: 1-Day Acuvue® Moist®;Device: Lens 2 (nelfilcon A)<br>* Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).<br>* Other names: Dailies® AquaComfort Plus®;Device: Lens 3 (nesofilcon A)<br>* Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).<br>* Other names: Biotrue ONEday;|
| Active Comparator: Lens 2/ Lens 3/ Lens 1<br>Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 2 (nelfilcon A), then wear Lens 3 (nesofilcon A) second and then wear Lens 1 (etafilcon A) third . | Device: Lens 1 (etafilcon A)<br>* Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).<br>* Other names: 1-Day Acuvue® Moist®;Device: Lens 2 (nelfilcon A)<br>* Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).<br>* Other names: Dailies® AquaComfort Plus®;Device: Lens 3 (nesofilcon A)<br>* Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).<br>* Other names: Biotrue ONEday;|
| Active Comparator: Lens 2 / Lens 1/ Lens 3<br>Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 2 (nelfilcon A), then wear Lens 1 (etafilcon A) second and then wear Lens 3 (nesofilcon A) third. Each lens type will be worn for approximately 2 weeks (12 +/- 2 days). | Device: Lens 1 (etafilcon A)<br>* Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).<br>* Other names: 1-Day Acuvue® Moist®;Device: Lens 2 (nelfilcon A)<br>* Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).<br>* Other names: Dailies® AquaComfort Plus®;Device: Lens 3 (nesofilcon A)<br>* Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).<br>* Other names: Biotrue ONEday;|
| Active Comparator: Lens 3 / Lens 1 / Lens 2<br>Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 3 (nesofilcon A), then wear Lens 1 (etafilcon A) second and then wear Lens 3 (nelfilcon A) third. | Device: Lens 1 (etafilcon A)<br>* Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).<br>* Other names: 1-Day Acuvue® Moist®;Device: Lens 2 (nelfilcon A)<br>* Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).<br>* Other names: Dailies® AquaComfort Plus®;Device: Lens 3 (nesofilcon A)<br>* Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).<br>* Other names: Biotrue ONEday;|
| Active Comparator: Lens 3 / Lens 2 / Lens 1<br>Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 3 (nesofilcon A), then wear Lens 2 (nelfilcon A) second and then wear Lens 3 (etafilcon A) third. | Device: Lens 1 (etafilcon A)<br>* Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).<br>* Other names: 1-Day Acuvue® Moist®;Device: Lens 2 (nelfilcon A)<br>* Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).<br>* Other names: Dailies® AquaComfort Plus®;Device: Lens 3 (nesofilcon A)<br>* Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).<br>* Other names: Biotrue ONEday;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Comfort | Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | 2- Week Follow-up |