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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226353
• Other study ID #: EX-MKTG-84
• Status: Completed
• Phase: N/A
• Start date: July 6, 2017
• Est. completion date: September 27, 2017

Study information

• Verified date: August 2019
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: September 27, 2017
• Est. primary completion date: September 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• somofilcon A
contact lens
• omafilcon A
contact lens

Locations

Country	Name	City	State
Canada	Center for Contact Lens Research, University of Waterloo	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Lens Fit - Lens Tightness	Graded using 0-100 scale (5% steps) where 0 = extremely loose and 100 = extremely tight.	Dispense and 1 week
Primary	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
Primary	Lens Fit - Centration	(3 point scale: optimum, decentration acceptable, decentration unacceptable)	Dispense and 1 Week
Primary	Lens Fit - Lens Wettability	Graded on a scale of 0-4 with 0.25 increments, 0=excellent; 4=severely reduced.	Dispense and 1 Week
Primary	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