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

NCT03226353 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-84
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (1)

somofilcon A 1-day soft contact lenses

EXPERIMENTAL

Habitual and refitted wearers of omafilcon A were refit into somofilcon A for a week

Device: somofilcon A; Device: omafilcon A

Interventions

somofilcon A DEVICE

contact lens

somofilcon A 1-day soft contact lenses

omafilcon A DEVICE

contact lens

somofilcon A 1-day soft contact lenses

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose A. Vega OD MSc FAAO
• Organization: CooperVision

javega@coopervision.com

(925) 621- 3761

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 21, 2017
• Study Start: July 6, 2017
• Primary Completion: September 27, 2017
• Study Completion: September 27, 2017
• Last Updated: September 12, 2019
• Results First Posted: February 4, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)