Back to resultsDehydration of Stenfilcon A Contact Lenses Versus Delefilcon A Contact Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
stenfilcon A
delefilcon A
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
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;
- Is a current wearer of soft contact lenses and has worn them (any brand) more than 3 months.
- Is able to wear lenses for at least 12 hours a day.
Exclusion Criteria:
- Is participating in any concurrent clinical 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;
Has undergone refractive error surgery;
- *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
- University of Waterloo School of Optometry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
stenfilcon A
delefilcon A
Arm Description
Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
Outcomes
Primary Outcome Measures
Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A
Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A
Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
Moisture Retention (Mean) of Stenfilcon A and Delefilcon A
Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
Moisture Retention (Median) of Stenfilcon A and Delefilcon A
Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
Secondary Outcome Measures
Subjective Comfort of Stenfilcon A and Delefilcon A
Subjective ratings for stenfilcon A and delefilcon A assessed at every hour up to 12 hours. (Scale 0-100, 0=very poor 100=excellent)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02366923
Brief Title
Dehydration of Stenfilcon A Contact Lenses Versus Delefilcon A Contact Lenses
Official Title
Dehydration of Stenfilcon A Contact Lenses Versus Delefilcon A Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
June 2015 (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 study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses.
Detailed Description
The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses. The primary outcome variable for this study is the loss in lens weight over the day, which will indicate the amount of dehydration that has occured.
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
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
stenfilcon A
Arm Type
Experimental
Arm Description
Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
Arm Title
delefilcon A
Arm Type
Active Comparator
Arm Description
Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
Intervention Type
Device
Intervention Name(s)
stenfilcon A
Intervention Description
Each subject randomized to wear either the test or control in either the left of right eye.
Intervention Type
Device
Intervention Name(s)
delefilcon A
Intervention Description
Each subject randomized to wear either the test or control in either the left of right eye.
Primary Outcome Measure Information:
Title
Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A
Description
Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
Time Frame
12 Hours of Wear
Title
Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A
Description
Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
Time Frame
12 Hours of Wear
Title
Moisture Retention (Mean) of Stenfilcon A and Delefilcon A
Description
Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
Time Frame
12 Hours of Wear
Title
Moisture Retention (Median) of Stenfilcon A and Delefilcon A
Description
Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
Time Frame
12 Hours of Wear
Secondary Outcome Measure Information:
Title
Subjective Comfort of Stenfilcon A and Delefilcon A
Description
Subjective ratings for stenfilcon A and delefilcon A assessed at every hour up to 12 hours. (Scale 0-100, 0=very poor 100=excellent)
Time Frame
Up to 12 Hours of Wear
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Is a current wearer of soft contact lenses and has worn them (any brand) more than 3 months.
Is able to wear lenses for at least 12 hours a day.
Exclusion Criteria:
Is participating in any concurrent clinical 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;
Has undergone refractive error surgery;
*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
Lydon Jones, PhD FC
Organizational Affiliation
Director, Centre for Contact Lens Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Farah Panjwani, BSc RAQ
Organizational Affiliation
Univerisy of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Waterloo School of Optometry
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Dehydration of Stenfilcon A Contact Lenses Versus Delefilcon A Contact Lenses
We'll reach out to this number within 24 hrs