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

Not Applicable

Completed

• Conditions: Myopia

• 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.

Study Timeline

• Study Start: 2017-07-06
• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-21
• Primary Completion: 2017-09-27
• Study Completion: 2017-09-27
• Results First Submitted: 2018-10-26
• Results First Submitted QC: 2019-01-31
• Results First Posted: 2019-02-04
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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.

Trial Locations

Locations (1)

Center for Contact Lens Research, University of Waterloo; 🇨🇦 Waterloo, Ontario, Canada