Back to resultsOverall Performance of a 1-day Silicone Hydrogel Lens When Habitual Soft Lens Wearers Are Refit
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
etafilcon A (control)
somofilcon A (test)
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
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.
Sites / Locations
- Center for Contact Lens Research, University of Waterloo
- University of Waterloo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Etafilcon A (control)
Somofilcon A (test)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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
Bulbar Hyperemia
Bulbar hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.
Limbal Hyperemia
Limbal hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.
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
Visual Acuity
High contrast visual acuity at high illumination was measured with each lens at each visit using a logMAR chart.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02588573
Brief Title
Overall Performance of a 1-day Silicone Hydrogel Lens When Habitual Soft Lens Wearers Are Refit
Official Title
Overall Performance of a 1-day Silicone Hydrogel Lens When Habitual Soft Lens Wearers Are Refit
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Etafilcon A (control)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Somofilcon A (test)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
etafilcon A (control)
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
somofilcon A (test)
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Comfort
Description
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.
Time Frame
8 hours
Title
Comfort Preference
Description
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
Time Frame
Baseline and 8 hours
Title
Bulbar Hyperemia
Description
Bulbar hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.
Time Frame
Baseline and 8 hours
Title
Limbal Hyperemia
Description
Limbal hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.
Time Frame
Baseline and 8 hours
Title
Conjunctival Staining
Description
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
Time Frame
8 hours
Title
Visual Acuity
Description
High contrast visual acuity at high illumination was measured with each lens at each visit using a logMAR chart.
Time Frame
Baseline and 8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD, FCOptom
Organizational Affiliation
Centre for Contact Lens Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Contact Lens Research, University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
Facility Name
University of Waterloo
City
Waterloo
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Overall Performance of a 1-day Silicone Hydrogel Lens When Habitual Soft Lens Wearers Are Refit
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