Overall Performance of a 1-day Silicone Hydrogel Lens When Habitual Soft Lens Wearers Are Refit

The objective of the study is to compare the overall subjective comfort profile over 8 hours of lens wear in two groups of habitual soft contact lens wearers (daily disposable hydrogel lenses and frequent replacement lenses) when refitted in to somofilcon A lenses.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: etafilcon A (control); Device: somofilcon A (test)

Detailed Description

This will be a prospective, single day, randomized, double-masked, non-dispensing, contralateral study. Participants were recruited into one of two groups - participants who habitually wore etafilcon A: daily disposable hydrogel lenses and participants who habitually wore frequent replacement lenses (FREQ).

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Waterloo, Canada
    • University of Waterloo
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Center for Contact Lens Research, University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A person is eligible for inclusion in the study if he/she:

  1. Is at least 17 years of age and has full legal capacity to volunteer;
  2. Has read and signed an information consent letter;
  3. Is willing and able to follow instructions and maintain the appointment schedule;
  4. Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction or the assigned study lenses;
  5. Habitually wears either etafilcon A lens or any frequent replacement contact lenses (as defined in 4.1.1);
  6. Habitually wear contact lenses with a power between -1.00 and -6.00D (Diopters) (inclusive) in both eyes;
  7. Demonstrates an acceptable fit with the study lenses;
  8. Is usually able to wear contact lenses for at least 8 hours per day.

Exclusion Criteria:

• A person will be excluded from the study if he/she:

  1. Is participating in any concurrent clinical or research study;
  2. Has any known active* ocular disease and/or infection;
  3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  5. Has known sensitivity to the diagnostic substances (pharmaceuticals), such as fluorescein dye, or products to be used in the study;
  6. Is aphakic;
  7. Has undergone refractive error surgery.

  8. Has participated in the previous somfofilcon A study (ORE# 20893)

     • For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Etafilcon A (control); Subjects in each of the habitual wearing groups will be randomized to wear either the test or control lens in either the left or right eye.	Device: etafilcon A (control); contact lens; Device: somofilcon A (test); contact lens
Active Comparator: Somofilcon A (test); Subjects in each of the habitual wearing groups will be randomized to wear either the test or control lens in either the left or right eye.	Device: etafilcon A (control); contact lens; Device: somofilcon A (test); contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort	Subjective ratings for lens comfort of etafilcon A and somofilcon A. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever.	8 hours
Comfort Preference	Lens preference in regards to comfort of etafilcon A and somofilcon A. Categories: Strongly prefer etafilcon A lens, slightly prefer etafilcon A lens, no preference, slightly prefer somofilcon A lens, strongly prefer somofilcon A lens	Baseline and 8 hours
Bulbar Hyperemia	Bulbar hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.	Baseline and 8 hours
Limbal Hyperemia	Limbal hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.	Baseline and 8 hours
Conjunctival Staining	Conjunctival staining was graded in each quadrant with scale 0-4, 0.5 steps, 0=normal, 4=severe of four areas: N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central	8 hours
Visual Acuity	High contrast visual acuity at high illumination was measured with each lens at each visit using a logMAR chart.	Baseline and 8 hours

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Lyndon Jones, PhD, FCOptom, Centre for Contact Lens Research

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: October 22, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Actual): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 5, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: EX-MKTG-61