Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A
- Conditions
- Myopia
- Interventions
- Device: somofilcon ADevice: omafilcon A
- Registration Number
- NCT03226353
- Lead Sponsor
- Coopervision, Inc.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description somofilcon A 1-day soft contact lenses somofilcon A Habitual and refitted wearers of omafilcon A were refit into somofilcon A for a week somofilcon A 1-day soft contact lenses omafilcon A Habitual and refitted wearers of omafilcon A were refit into somofilcon A for a week
- Primary Outcome Measures
Name Time Method Lens Fit - Post-blink Lens Movement Dispense and 1 Week Graded on a scale of 0-4, 1 step, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement.
Lens Fit - Lens Tightness Dispense and 1 week Graded using 0-100 scale (5% steps) where 0 = extremely loose and 100 = extremely tight.
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? 1 week 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)
Lens Fit - Lens Deposition Dispense and 1 week Graded on a scale of 0-4, with 0.25 increments, 0=no deposits; 4=deposit ≥ 0.5mm or film \>75% surface.
Lens Fit - Centration Dispense and 1 Week (3 point scale: optimum, decentration acceptable, decentration unacceptable)
Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A? 1 week 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)
Overall Lens Fit Acceptance Dispense and 1 Week Graded on a 0-4 point scale (where 0 = should not be worn, 4=perfect), providing a reason if Grade 2 or less
Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A? 1 week 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)
Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day? 1 week 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)
Lens Fit - Lens Wettability Dispense and 1 Week Graded on a scale of 0-4 with 0.25 increments, 0=excellent; 4=severely reduced.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Center for Contact Lens Research, University of Waterloo
🇨🇦Waterloo, Ontario, Canada