Evaluation of 8.5 vs 9.0 Base Curve for 1-DAY ACUVUE(r) TruEye(r) Brand Contact Lenses

Study Overview
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Brief Summary
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The objective of this study is to determine if corneal diameter and keratometry readings correlate to subjective comfort and lens fitting characteristics.

Conditions
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Contact Lens Base Curve (BC) Fit and Comfort

Intervention / Treatment
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* Device: Contact Lenses with 8.5 BC
* Device: Contact Lenses with 9.0 BC


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 be no less than 18 and no more than 45 years of age with no presbyopic add. The subject must be willing and able to adhere to the instructions set out in the protocol. The subject must be an adapted soft contact lens wearer in both eyes. The subject must be willing to wear the study contact lenses up to 14 hours/day. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 Diopters (D) to -6.00 D in each eye. The subject must have refractive cylinder less than or equal to 1.00 D in each eye. The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye. The subject must require a visual correction in both eyes (no monofit or monovision allowed). The subject must have normal eyes (i.e., no ocular medications or infections of any type). Exclusion Criteria: Current 1-DAY ACUVUE® TruEye® wearers Anisometropia of 1.00 D or greater Any Ocular or systemic allergies or diseases which might interfere with contact lens wear. Any Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear. 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. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. Any ocular infection Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear Pregnancy or lactation Diabetes Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV). Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test/Control - Phase 1<br>Over visits 1 and 2, subject will wear Contact Lenses with 8.5 BC in right eye and Contact Lenses with 9.0 BC in left eye in a contralateral manner. | Device: Contact Lenses with 8.5 BC<br>* Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.<br>* Other names: Marketed Daily Disposable Soft Contact Lenses;Device: Contact Lenses with 9.0 BC<br>* Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.<br>* Other names: Marketed Daily Disposable Soft Contact Lenses;|
| Experimental: Control/Test - Phase 1<br>Over visits 1 and 2, subject will wear Contact Lenses with 9.0 BC in right eye and Contact Lenses with 8.5 BC in left eye in a contralateral manner. | Device: Contact Lenses with 8.5 BC<br>* Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.<br>* Other names: Marketed Daily Disposable Soft Contact Lenses;Device: Contact Lenses with 9.0 BC<br>* Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.<br>* Other names: Marketed Daily Disposable Soft Contact Lenses;|
| Experimental: Test/Control - Phase 2<br>During Phase 2, subjects will wear a pair of Contact Lenses with 9.0 BC at Period 1 and Contact Lenses with 8.5 BC at Period 2 in a bilateral manner. | Device: Contact Lenses with 8.5 BC<br>* Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.<br>* Other names: Marketed Daily Disposable Soft Contact Lenses;Device: Contact Lenses with 9.0 BC<br>* Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.<br>* Other names: Marketed Daily Disposable Soft Contact Lenses;|
| Experimental: Control/Test - Phase 2<br>During Phase 2, subjects will wear a pair of Contact Lenses with 8.5 BC at Period 1 and Contact Lenses with 9.0 BC at Period 2 in a bilateral manner. | Device: Contact Lenses with 8.5 BC<br>* Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.<br>* Other names: Marketed Daily Disposable Soft Contact Lenses;Device: Contact Lenses with 9.0 BC<br>* Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.<br>* Other names: Marketed Daily Disposable Soft Contact Lenses;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation Between Subjective CLUE Comfort and Keratometry | CLUE- The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable 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) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ. Et al. August 2016). Keratometry measurements of major keratometric meridians (diopter [DK]) and their location (degrees) was collected at baseline for both eyes. The correlation between CLUE comfort and maximum Keratometry measurements of the two eyes within each subject and the correlation between CLUE comfort and the minimum Keratometry measurements of the two eyes within each subject were reported. | 3-day follow-up | 
| Correlation Between Subjective CLUE Comfort and Corneal Diameter | Assessment The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable 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) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ Et al. August 2016). Corneal diameter (horizontal visible iris diameter [HVID]) was collected at baseline for both eyes using a slit lamp reticle, measuring to the nearest 0.05 mm.The maximum (or minimum) measurements of HVID between the two eyes of each subject were used for correlation analyses between subjective CLUE comfort score and corneal diameter. | 3-day follow-up |