Back to resultsA Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
silicone hydrogel lens (test)
enfilcon A lens (control)
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 understood the information consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses
- Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each 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 pharmaceuticals to be used in the study
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
- Is aphakic
- Has undergone corneal refractive 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. Participants will be excluded with significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 3 or above: corneal edema, tarsal abnormalities, and conjunctival injection) or active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)
For the purposes of this study, participants will be excluded**, if currently taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
Sites / Locations
- Center for Contact Lens Research, University of Waterloo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
silicone hydrogel lens (test)
enfilcon A lens (control)
Arm Description
Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
Outcomes
Primary Outcome Measures
Comfort
Subjective ratings scale (0-100) assessed: 0=Cannot be worn, causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever. Time points for comfort: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.
Dryness
Subjective ratings scale (0-100): 0=Cannot be worn, extremely dry, 20=Frequently Irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=No dryness experienced at any time. Time points for dryness: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.
Secondary Outcome Measures
Lens Wettability
Grading scale 0-4, 0.25 steps, 0=excellent; 4=severely reduced.
Surface Appearance
Grade ratings category (smooth, grainy, or other)
Surface Appearance
Grade ratings category (smooth, grainy, or other)
High Contrast Acuity at High Room Illumination
Logarithm of the Minimum Angle or Resolution (LogMAR) Chart
Lens Deposition
Lens Deposits Scale 0-4, 0.25 steps. 0=excellent; 4=severely reduced
Lens Problems
Lenses were evaluated for defects, scratches, fibers, blue specks, and other findings.
Lens Centration
Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.
(mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior
Lens Centration
Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.
(mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior
Post-blink Movement
Post-blink movement evaluated by estimating the distance the lens was moving immediately after a blink. Primary Gaze: (mm, 0.1 steps)
Lens Tightness
Lens tightness Scale 0%-100%, 0%=extremely loose fit, 50%=optimal push resistance and smooth return, 100%=no movement.
Visual Quality
Subjective ratings scale (0-100): 0=Extremely poor vision all of the time; cannot function, 20=Frequently annoying vision problems, 40=Occasionally annoying vision problems, 60=Occasionally noticeable but not annoying vision problems, 80=Rarely noticeable vision problems, 100=Excellent vision all of the time. Different time points were taken for vision quality: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.
Ease of Lens Insertion
Subjective ratings scale (0-100): 0=Could not place lens on eye, 20=Frequently takes multiple attempts to place on eye; often unsuccessful, 40=Frequently takes multiple attempts to place on eye, 60=Occasionally takes a few attempts to place on eye, 80=Rarely difficult to place on eye, 100=Always easy to place lens on eye
Ease of Lens Removal
Subjective ratings scale (0-100): 0=Could not remove lens from eye, 20=Frequently takes multiple attempts to remove from eye; often unsuccessful, 40=Frequently takes multiple attempts to remove from eye, 60=Occasionally takes a few attempts to remove from eye, 80=Rarely difficult to remove from eye, 100=Always easy to remove lens from eye.
Overall Lens Fit
Overall Lens Fit Scale 0-4, 0.25 steps 0=Very poor (lens should not be worn at all);
Poor (lens could be worn with supervision only);
Fair (would prefer to refit, but clinically acceptable);
Good (fit could be slightly improved);
Very good (optimal)
Bulbar Hyperemia
Bulbar hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.
Limbal Hyperemia
Limbal hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.
Corneal Dehydration Staining
Corneal Staining: Dehydration Staining: Yes/No
Corneal Staining (Extent)
Corneal staining extent, grade as % of each zone:
C - Central, N - Nasal, T - Temporal, S - Superior, I - Interior
Conjunctival Indentation
Conjunctival Indentation 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4, 0.5 steps; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Conjunctival Staining
Conjunctival Staining 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4; 0.5 steps, 0=None,1=Minimal diffuse punctuate, 2=Coalescent punctuate, 3=Confluent, 4=Deep confluent
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02500368
Brief Title
A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week
Official Title
A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 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
This is a 1-week dispensing, double-masked, randomized, bilateral study comparing the test lens against the control lens.
Detailed Description
The order of lens wear (test lens first, control lens second or control lens first, test lens second) will be selected according to a randomization table.
Both test and control lenses will be used in a daily wear modality for 1 week. It is anticipated that this study will involve following visits: Baseline (screening and dispense of 1st study pair of lenses, visit combined), 1-week visit (follow-up of the 1st study pair of lenses and dispense the 2nd study pair of lenses) and 2-week visit (1 week follow-up of the 2nd study pair of lenses).
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
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
silicone hydrogel lens (test)
Arm Type
Experimental
Arm Description
Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
Arm Title
enfilcon A lens (control)
Arm Type
Active Comparator
Arm Description
Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
Intervention Type
Device
Intervention Name(s)
silicone hydrogel lens (test)
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
enfilcon A lens (control)
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Comfort
Description
Subjective ratings scale (0-100) assessed: 0=Cannot be worn, causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever. Time points for comfort: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.
Time Frame
Baseline and 1 week
Title
Dryness
Description
Subjective ratings scale (0-100): 0=Cannot be worn, extremely dry, 20=Frequently Irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=No dryness experienced at any time. Time points for dryness: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.
Time Frame
Baseline and 1 week
Secondary Outcome Measure Information:
Title
Lens Wettability
Description
Grading scale 0-4, 0.25 steps, 0=excellent; 4=severely reduced.
Time Frame
Baseline and 1 week
Title
Surface Appearance
Description
Grade ratings category (smooth, grainy, or other)
Time Frame
Baseline
Title
Surface Appearance
Description
Grade ratings category (smooth, grainy, or other)
Time Frame
1 week
Title
High Contrast Acuity at High Room Illumination
Description
Logarithm of the Minimum Angle or Resolution (LogMAR) Chart
Time Frame
Baseline and 1 week
Title
Lens Deposition
Description
Lens Deposits Scale 0-4, 0.25 steps. 0=excellent; 4=severely reduced
Time Frame
Baseline and 1 week
Title
Lens Problems
Description
Lenses were evaluated for defects, scratches, fibers, blue specks, and other findings.
Time Frame
Baseline and 1 week
Title
Lens Centration
Description
Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.
(mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior
Time Frame
Baseline
Title
Lens Centration
Description
Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.
(mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior
Time Frame
1 week
Title
Post-blink Movement
Description
Post-blink movement evaluated by estimating the distance the lens was moving immediately after a blink. Primary Gaze: (mm, 0.1 steps)
Time Frame
Baseline and 1 week
Title
Lens Tightness
Description
Lens tightness Scale 0%-100%, 0%=extremely loose fit, 50%=optimal push resistance and smooth return, 100%=no movement.
Time Frame
Baseline and 1 week
Title
Visual Quality
Description
Subjective ratings scale (0-100): 0=Extremely poor vision all of the time; cannot function, 20=Frequently annoying vision problems, 40=Occasionally annoying vision problems, 60=Occasionally noticeable but not annoying vision problems, 80=Rarely noticeable vision problems, 100=Excellent vision all of the time. Different time points were taken for vision quality: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.
Time Frame
Baseline and 1 week
Title
Ease of Lens Insertion
Description
Subjective ratings scale (0-100): 0=Could not place lens on eye, 20=Frequently takes multiple attempts to place on eye; often unsuccessful, 40=Frequently takes multiple attempts to place on eye, 60=Occasionally takes a few attempts to place on eye, 80=Rarely difficult to place on eye, 100=Always easy to place lens on eye
Time Frame
Baseline and 1 week
Title
Ease of Lens Removal
Description
Subjective ratings scale (0-100): 0=Could not remove lens from eye, 20=Frequently takes multiple attempts to remove from eye; often unsuccessful, 40=Frequently takes multiple attempts to remove from eye, 60=Occasionally takes a few attempts to remove from eye, 80=Rarely difficult to remove from eye, 100=Always easy to remove lens from eye.
Time Frame
1 week
Title
Overall Lens Fit
Description
Overall Lens Fit Scale 0-4, 0.25 steps 0=Very poor (lens should not be worn at all);
Poor (lens could be worn with supervision only);
Fair (would prefer to refit, but clinically acceptable);
Good (fit could be slightly improved);
Very good (optimal)
Time Frame
Baseline and 1 week
Title
Bulbar Hyperemia
Description
Bulbar hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.
Time Frame
Baseline and 1 week
Title
Limbal Hyperemia
Description
Limbal hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.
Time Frame
Baseline and 1 week
Title
Corneal Dehydration Staining
Description
Corneal Staining: Dehydration Staining: Yes/No
Time Frame
1 week
Title
Corneal Staining (Extent)
Description
Corneal staining extent, grade as % of each zone:
C - Central, N - Nasal, T - Temporal, S - Superior, I - Interior
Time Frame
Baseline and 1 week
Title
Conjunctival Indentation
Description
Conjunctival Indentation 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4, 0.5 steps; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Time Frame
Baseline and 1 week.
Title
Conjunctival Staining
Description
Conjunctival Staining 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4; 0.5 steps, 0=None,1=Minimal diffuse punctuate, 2=Coalescent punctuate, 3=Confluent, 4=Deep confluent
Time Frame
Baseline and 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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 understood the information consent letter
Is willing and able to follow instructions and maintain the appointment schedule
Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses
Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each 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 pharmaceuticals to be used in the study
Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
Is aphakic
Has undergone corneal refractive 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. Participants will be excluded with significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 3 or above: corneal edema, tarsal abnormalities, and conjunctival injection) or active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)
For the purposes of this study, participants will be excluded**, if currently taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD FCO
Organizational Affiliation
Center for Contact Lens Research, University of Waterloo
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
12. IPD Sharing Statement
Learn more about this trial
A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week
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