Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A

Study Overview
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Brief Summary
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The objective of the study is to determine if habitual or adapted contact lens wearers of Omafilcon A can be confidently refit into Somofilcon A lenses and be successful after one week of daily wear. The primary outcome variables for this study are: Investigator responses to refit questions; Lens fit.

Detailed Description
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This is a prospective, single-site, dispensing, bilateral wear, open label, daily wear switch study, with the test lens (Somofilcon A) being worn for 7 (+5) days.

Official Title
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Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A

Conditions
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Myopia

Intervention / Treatment
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* Device: somofilcon A
* Device: omafilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Habitually wears soft spherical contact lenses with a power between +6.00 to -10.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day; Habitually wears, or is able to be adequately refit into Proclear 1 Day lenses; Demonstrates an acceptable fit with Proclear 1 Day and Clariti 1 Day contact lenses; Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in each eye) with the study lenses or habitual correction; Manifest cylindrical spectacle refraction does not exceed -1.00DC in either eye. Exclusion Criteria: Is participating in any concurrent clinical 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 pharmaceuticals to be used in the study; Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal communication); Is aphakic; Has undergone refractive error surgery; Is an employee of the Centre for Contact Lens Research; Has taken part in another clinical or (pharmaceutical) research study within the last 7 days.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: somofilcon A 1-day soft contact lenses<br>Habitual and refitted wearers of omafilcon A were refit into somofilcon A for a week | Device: somofilcon A<br>* contact lens<br>Device: omafilcon A<br>* contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A? | Investigator level of agreement using a Likert scale on refitting participants from omafilcon A to somofilcon A at Visit 1 (Strongly Agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree) | 1 week | 
| Investigator Assessment to Refit- Based on the Investigator Opinion and Lens Fit Outcomes, Would the Investigator Refit the Subject Into Somofilcon A From Omafilcon A? | Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree) | 1 week | 
| Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day? | Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree) | 1 week | 
| Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A? | Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree) | 1 week | 
| Lens Fit - Post-blink Lens Movement | Graded on a scale of 0-4, 1 step, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement. | Dispense and 1 Week | 
| Lens Fit - Lens Tightness | Graded using 0-100 scale (5% steps) where 0 = extremely loose and 100 = extremely tight. | Dispense and 1 week | 
| Lens Fit - Lens Deposition | Graded on a scale of 0-4, with 0.25 increments, 0=no deposits; 4=deposit ≥ 0.5mm or film >75% surface. | Dispense and 1 week | 
| Lens Fit - Centration | (3 point scale: optimum, decentration acceptable, decentration unacceptable) | Dispense and 1 Week | 
| Lens Fit - Lens Wettability | Graded on a scale of 0-4 with 0.25 increments, 0=excellent; 4=severely reduced. | Dispense and 1 Week | 
| Overall Lens Fit Acceptance | Graded on a 0-4 point scale (where 0 = should not be worn, 4=perfect), providing a reason if Grade 2 or less | Dispense and 1 Week |