Overall Performance of a 1-day Silicone Hydrogel Lens When Habitual Soft Lens Wearers Are Refit

Study Overview
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Brief Summary
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The objective of the study is to compare the overall subjective comfort profile over 8 hours of lens wear in two groups of habitual soft contact lens wearers (daily disposable hydrogel lenses and frequent replacement lenses) when refitted in to somofilcon A lenses.

Detailed Description
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This will be a prospective, single day, randomized, double-masked, non-dispensing, contralateral study. Participants were recruited into one of two groups - participants who habitually wore etafilcon A: daily disposable hydrogel lenses and participants who habitually wore frequent replacement lenses (FREQ).

Official Title
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Overall Performance of a 1-day Silicone Hydrogel Lens When Habitual Soft Lens Wearers Are Refit

Conditions
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Myopia

Intervention / Treatment
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* Device: etafilcon A (control)
* Device: somofilcon A (test)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A person is eligible for inclusion in the study if he/she: Is at least 17 years of age and has full legal capacity to volunteer; Has read and signed an information consent letter; Is willing and able to follow instructions and maintain the appointment schedule; Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction or the assigned study lenses; Habitually wears either etafilcon A lens or any frequent replacement contact lenses (as defined in 4.1.1); Habitually wear contact lenses with a power between -1.00 and -6.00D (Diopters) (inclusive) in both eyes; Demonstrates an acceptable fit with the study lenses; Is usually able to wear contact lenses for at least 8 hours per day. Exclusion Criteria: A person will be excluded from the study if he/she: Is participating in any concurrent clinical or research study; Has any known active* ocular disease and/or infection; Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; Has known sensitivity to the diagnostic substances (pharmaceuticals), such as fluorescein dye, or products to be used in the study; Is aphakic; Has undergone refractive error surgery. Has participated in the previous somfofilcon A study (ORE# 20893) For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Ages Eligible for Study
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Minimum Age: 17 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Etafilcon A (control)<br>Subjects in each of the habitual wearing groups will be randomized to wear either the test or control lens in either the left or right eye. | Device: etafilcon A (control)<br>* contact lens<br>Device: somofilcon A (test)<br>* contact lens<br>|
| Active Comparator: Somofilcon A (test)<br>Subjects in each of the habitual wearing groups will be randomized to wear either the test or control lens in either the left or right eye. | Device: etafilcon A (control)<br>* contact lens<br>Device: somofilcon A (test)<br>* contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort | Subjective ratings for lens comfort of etafilcon A and somofilcon A. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever. | 8 hours | 
| Comfort Preference | Lens preference in regards to comfort of etafilcon A and somofilcon A. Categories: Strongly prefer etafilcon A lens, slightly prefer etafilcon A lens, no preference, slightly prefer somofilcon A lens, strongly prefer somofilcon A lens | Baseline and 8 hours | 
| Bulbar Hyperemia | Bulbar hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe. | Baseline and 8 hours | 
| Limbal Hyperemia | Limbal hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe. | Baseline and 8 hours | 
| Conjunctival Staining | Conjunctival staining was graded in each quadrant with scale 0-4, 0.5 steps, 0=normal, 4=severe of four areas: N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central | 8 hours | 
| Visual Acuity | High contrast visual acuity at high illumination was measured with each lens at each visit using a logMAR chart. | Baseline and 8 hours |