Assessment of Daily Disposable Silicone Hydrogel Lens Wear

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of an investigational silicone hydrogel soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle wearers.

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Narafilcon B Contact Lens
* Device: Spectacles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to read, comprehend and sign an informed consent (or parental consent/subject assent, as appropriate). Willing to comply with the study visit schedule. Ages 15 to 39. Has access to a cellular telephone with text messaging capabilities. Has a current pair of spectacles. 'Neophyte' - In this work, 'neophyte' will be taken to mean any subject who has never been dispensed contact lenses. A subject who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses, will also be classified as a 'neophyte'. Spherical contact lens (CL) prescription between -0.75D and -6.00D and spectacle cylinder equal to or less than 0.75 DC. Monocular best-corrected distance visual acuity (VA) ≥ 20/30 Snellen in each eye. Subject agrees to intent of wearing the CLs at minimum 6 hours/day for at least 4 days per week. They agree not to participate in other clinical research during the duration of this study. Exclusion Criteria: Active ocular allergy, infection, injury, inflammation, or abnormality (e.g., keratoconus) that might interfere with soft contact lens wear. Prior corneal refractive surgery or corneal irregularity (e.g., keratoconus). Systemic disease, which might interfere with contact lens wear. Medication usage that may be associated with eye dryness. Use of any topical medication such as eye drops or ointment. Pregnant or lactating (by self-report). Aphakia. Grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear. Have participated in any other clinical trial or research in the two weeks prior to starting this study.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 39 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Narafilcon B Contact Lens<br>Investigational Silicone Hydrogel Contact Lens | Device: Narafilcon B Contact Lens<br> <br> * Other names: Investigational Silicone Hydrogel;|
| Active Comparator: Spectacles<br> | Device: Spectacles<br>* spectacle wearers<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Papillary Conjunctivitis | Swelling of the papillary (Papillary conjunctivitis) area of the eye was assessed using a slit-lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score. | 1 Year | 
| Conjunctival Hyperemia | Comparison of the amount of redness in the conjunctival area of the eye, between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score. | 1 Year | 
| Limbal Hyperemia | Swelling of the vessels in the limbal area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score. | 1 Year | 
| Corneal Staining | Abrasions in the cornea area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. | 1 Year | 
| Conjunctival Staining | Mild abrasions of the conjunctival area of the eye. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score. | 1 Year | 
| Corneal Neovascularization | New vascularization of the Cornea. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score. | 1 Year | 
| Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire | The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores 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. The differences between: (final visit and first visit) and then (final visit and 6 months) are reported. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfortable Wearing Time | Average numbers of overall average daily contact lens wear hours and average daily comfortable wear hours as reported at each follow-up visit. | 1 Year |