Skip to main content
OpenTrials
Completed

NCT Number: NCT02588573

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.

Completed

Looking for future studies?

Notify Me

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, Canada

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • A person is eligible for inclusion in the study if he/she:
  • 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;
  • Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction or the assigned study lenses;
  • Habitually wears either etafilcon A lens or any frequent replacement contact lenses (as defined in 4.1.1);
  • Habitually wear contact lenses with a power between -1.00 and -6.00D (Diopters) (inclusive) in both eyes;
  • Demonstrates an acceptable fit with the study lenses;
  • 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:
  • Is participating in any concurrent clinical or 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 substances (pharmaceuticals), such as fluorescein dye, or products to be used in the study;
  • Is aphakic;
  • Has undergone refractive error surgery.
  • 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.

Treatment and study plan

etafilcon A (control)

Device

contact lens

somofilcon A (test)

Device

contact lens

Primary outcomes

  1. Comfort

    Time frame: 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.

  2. Comfort Preference

    Time frame: 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

  3. Bulbar Hyperemia

    Time frame: Baseline and 8 hours

    Bulbar hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.

  4. Limbal Hyperemia

    Time frame: Baseline and 8 hours

    Limbal hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.

  5. Conjunctival Staining

    Time frame: 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

  6. Visual Acuity

    Time frame: Baseline and 8 hours

    High contrast visual acuity at high illumination was measured with each lens at each visit using a logMAR chart.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 28, 2015
Registry last updated
Feb 8, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.