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Completed

NCT Number: NCT03226353

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

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

somofilcon A

Device

contact lens

omafilcon A

Device

contact lens

Primary outcomes

  1. Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A?

    Time frame: 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)

  2. 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?

    Time frame: 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)

  3. Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day?

    Time frame: 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)

  4. Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A?

    Time frame: 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)

  5. Lens Fit - Post-blink Lens Movement

    Time frame: Dispense and 1 Week

    Graded on a scale of 0-4, 1 step, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement.

  6. Lens Fit - Lens Tightness

    Time frame: Dispense and 1 week

    Graded using 0-100 scale (5% steps) where 0 = extremely loose and 100 = extremely tight.

  7. Lens Fit - Lens Deposition

    Time frame: 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.

  8. Lens Fit - Centration

    Time frame: Dispense and 1 Week

    (3 point scale: optimum, decentration acceptable, decentration unacceptable)

  9. Lens Fit - Lens Wettability

    Time frame: Dispense and 1 Week

    Graded on a scale of 0-4 with 0.25 increments, 0=excellent; 4=severely reduced.

  10. Overall Lens Fit Acceptance

    Time frame: 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

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 21, 2017
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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