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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: etafilcon A (control); Device: somofilcon A (test)

• Registration Number: NCT02588573
• Lead Sponsor: Coopervision, Inc.

Brief Summary

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.

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-28
• Primary Completion: 2016-03
• Study Completion: 2016-04
• Results First Submitted: 2017-01-30
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-05
• Last Update Submitted: 2019-02-05
• Results First Posted: 2019-02-08
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Etafilcon A (control)	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.
Somofilcon A (test)	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.
Somofilcon A (test)	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.
Etafilcon A (control)	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.

Primary Outcome Measures

Name	Time	Method
Comfort	8 hours	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.
Comfort Preference	Baseline and 8 hours	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
Bulbar Hyperemia	Baseline and 8 hours	Bulbar hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.
Limbal Hyperemia	Baseline and 8 hours	Limbal hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.
Conjunctival Staining	8 hours	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
Visual Acuity	Baseline and 8 hours	High contrast visual acuity at high illumination was measured with each lens at each visit using a logMAR chart.

Trial Locations

Locations (2)

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

University of Waterloo; 🇨🇦 Waterloo, Canada