Back to resultsBilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism
Primary Purpose
Astigmatism
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
stenfilcon A toric lens
etafilcon A toric lens
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism
Eligibility Criteria
Inclusion Criteria:
- Is at least 17 years of age for Canada and 18 years of age for the USA 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 an adapted soft contact lens wearer;
- Requires a spherical contact lens prescription between -1.00 to -6.00 inclusive in each eye
- Has spectacle astigmatism: -0.50 to -1.50D (Diopter) cylinder (Axis: 90±20, 180±20 in both eyes);
- Willing to wear contact lens in both eyes for at least 8 hours per day, 7 days per week;
- Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye;
- To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable.
Exclusion Criteria:
- 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 (by verbal confirmation at the screening visit);
- Is aphakic;
- Has undergone refractive error surgery
Sites / Locations
- Clinical Research Center, University of California, Berkeley
- Center for Contact Lens Research, University of Waterloo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
stenfilcon A toric lens
etafilcon A toric lens
Arm Description
Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
Outcomes
Primary Outcome Measures
Comfort
Subjective ratings of lens performance for comfort assessed at baseline and 1 week. Comfort Scale 0-100, 0=extremely uncomfortable/cannot tolerate, 100=extremely comfortable/cannot be felt.
Handling
Subjective ratings of lens performance for handling assessed at baseline and 1 week. Handling Scale 0-100, 0=very difficult to handle, 100=very easy to handle.
Vision
Subjective ratings of lens performance for vision assessed at baseline and 1 week. Scale 0-100, 0=extremely poor vision all of the time, cannot function, 100=excellent.
High Visual Acuity
High illumination high contrast (HIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.
Low Visual Acuity
Low illumination high contrast (LIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.
Lens Surface - Wettability
Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=severely reduced, 4=excellent wettability.
Lens Surface - Deposits
Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=no deposits, 4=severe deposits.
Corneal Staining, Type
Ocular health of corneal staining, type for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining, 4=Severe staining Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior
Corneal Staining, Extent
Ocular health of corneal staining (extent) for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining 1=1-15% of area 2=16-30% of area 3=31-45% of area 4=>45% of area Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior
Conjunctival Staining
Ocular health of conjunctival staining for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Measured in 0.50 steps, scale 0-4, 0=None, 1=Minimal diffuse punctate, 2=Coalescent punctate, 3=Confluent, 4= Deep confluent
N - Nasal, T - Temporal, S - Superior, I - Inferior
Lens Durability
Lens durability (lens tearing) between stenfilcon A toric lens or etafilcon A toric lens assessed at 1 week. (The number of lens tear or lens nicks found during the one week study).
Lens Fit Acceptance
Lens fit acceptance (on eye stability) for stenfilcon A and etafilcon A assessed at baseline and 1 week. Scale 0-4, 0=Can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Secondary Outcome Measures
Dryness
Subjective ratings of lens performance for dryness assessed during the day and at the end of the day. Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time.
Overall Satisfaction
Overall satisfaction of stenfilcon A and etafilcon A lenses. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02410824
Brief Title
Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism
Official Title
Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 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
Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism.
Detailed Description
CooperVision is evaluating the clinical performance of an FDA cleared silicone-hydrogel lens material stenfilcon A (test) compared to etafilcon A for Astigmatism lens (control) when worn on a daily wear basis over one (1) week in a randomized, bilateral, cross-over, dispensing study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
stenfilcon A toric lens
Arm Type
Experimental
Arm Description
Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
Arm Title
etafilcon A toric lens
Arm Type
Active Comparator
Arm Description
Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
Intervention Type
Device
Intervention Name(s)
stenfilcon A toric lens
Intervention Description
toric contact lens
Intervention Type
Device
Intervention Name(s)
etafilcon A toric lens
Intervention Description
toric contact lens
Primary Outcome Measure Information:
Title
Comfort
Description
Subjective ratings of lens performance for comfort assessed at baseline and 1 week. Comfort Scale 0-100, 0=extremely uncomfortable/cannot tolerate, 100=extremely comfortable/cannot be felt.
Time Frame
Baseline and 1 Week
Title
Handling
Description
Subjective ratings of lens performance for handling assessed at baseline and 1 week. Handling Scale 0-100, 0=very difficult to handle, 100=very easy to handle.
Time Frame
Baseline and 1 Week
Title
Vision
Description
Subjective ratings of lens performance for vision assessed at baseline and 1 week. Scale 0-100, 0=extremely poor vision all of the time, cannot function, 100=excellent.
Time Frame
Baseline and 1 Week
Title
High Visual Acuity
Description
High illumination high contrast (HIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.
Time Frame
Baseline and 1 Week
Title
Low Visual Acuity
Description
Low illumination high contrast (LIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.
Time Frame
Baseline and 1 Week
Title
Lens Surface - Wettability
Description
Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=severely reduced, 4=excellent wettability.
Time Frame
Baseline and 1 Week
Title
Lens Surface - Deposits
Description
Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=no deposits, 4=severe deposits.
Time Frame
Baseline and 1 Week
Title
Corneal Staining, Type
Description
Ocular health of corneal staining, type for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining, 4=Severe staining Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior
Time Frame
Baseline and 1 week
Title
Corneal Staining, Extent
Description
Ocular health of corneal staining (extent) for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining 1=1-15% of area 2=16-30% of area 3=31-45% of area 4=>45% of area Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior
Time Frame
Baseline and 1 week
Title
Conjunctival Staining
Description
Ocular health of conjunctival staining for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Measured in 0.50 steps, scale 0-4, 0=None, 1=Minimal diffuse punctate, 2=Coalescent punctate, 3=Confluent, 4= Deep confluent
N - Nasal, T - Temporal, S - Superior, I - Inferior
Time Frame
Baseline and 1 week
Title
Lens Durability
Description
Lens durability (lens tearing) between stenfilcon A toric lens or etafilcon A toric lens assessed at 1 week. (The number of lens tear or lens nicks found during the one week study).
Time Frame
1 Week
Title
Lens Fit Acceptance
Description
Lens fit acceptance (on eye stability) for stenfilcon A and etafilcon A assessed at baseline and 1 week. Scale 0-4, 0=Can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Time Frame
Baseline and 1 Week
Secondary Outcome Measure Information:
Title
Dryness
Description
Subjective ratings of lens performance for dryness assessed during the day and at the end of the day. Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time.
Time Frame
1 Week
Title
Overall Satisfaction
Description
Overall satisfaction of stenfilcon A and etafilcon A lenses. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied.
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:
Is at least 17 years of age for Canada and 18 years of age for the USA 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 an adapted soft contact lens wearer;
Requires a spherical contact lens prescription between -1.00 to -6.00 inclusive in each eye
Has spectacle astigmatism: -0.50 to -1.50D (Diopter) cylinder (Axis: 90±20, 180±20 in both eyes);
Willing to wear contact lens in both eyes for at least 8 hours per day, 7 days per week;
Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye;
To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable.
Exclusion Criteria:
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 (by verbal confirmation at the screening visit);
Is aphakic;
Has undergone refractive error surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meng C Lin, OD PhD
Organizational Affiliation
UC Berkeley Clinical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Center, University of California, Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
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
Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism
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