Back to resultsA Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks
Primary Purpose
Myopia, Hyperopia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Sapphire
senofilcon 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 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 spectacle lens powers between -0.50 to -6.00 diopters sphere (0.25D steps) or +1.00 to +8.00 diopters sphere (1.00D steps)
- Has no more than 0.75 diopters of refractive astigmatism
- Willing to wear contact lens in both eyes
- 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 or planning a pregnancy at the time of enrolment (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
Sapphire
senofilcon A
Arm Description
Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study.
Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study.
Outcomes
Primary Outcome Measures
Vision Quality
Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)
Vision Quality
Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)
Vision Quality
Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)
Subjective Rating for Comfort.
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Subjective Rating for Comfort.
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Subjective Rating for Comfort.
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Lens Surface Wettability
Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)
Lens Surface Wettability
Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)
Surface Deposits
Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = <5 deposits; 2 = >5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits >0.5mm or film > 75% of surface)
Surface Deposits
Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = <5 deposits; 2 = >5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits >0.5mm or film > 75% of surface)
Lens Handling (Ease of Insertion)
Lens handling - ease of insertion of the lenses. Scale 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye.
Lens Handling (Ease of Removal)
Lens handling - ease of removal of the lenses. Scale 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye.
Subjective Preference for Comfort.
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Subjective Preference for Comfort.
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02345811
Brief Title
A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks
Official Title
A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the clinical performance of an investigational silicone-hydrogel lens when worn on a daily wear modality over two weeks of lens wear.
Detailed Description
This was a randomized, bilateral, 2 week cross over, double-masked, dispensing study comparing Sapphire test lens against the senofilcon A control lens. This study results were not used to support design validation of the test lens.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hyperopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sapphire
Arm Type
Experimental
Arm Description
Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study.
Arm Title
senofilcon A
Arm Type
Active Comparator
Arm Description
Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study.
Intervention Type
Device
Intervention Name(s)
Sapphire
Intervention Description
silicone-hydrogel contact lens
Intervention Type
Device
Intervention Name(s)
senofilcon A
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Vision Quality
Description
Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)
Time Frame
Baseline (10 minutes post lens settling at dispense)
Title
Vision Quality
Description
Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)
Time Frame
2 weeks - During the Day
Title
Vision Quality
Description
Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)
Time Frame
2 weeks - End of Day
Title
Subjective Rating for Comfort.
Description
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Time Frame
Baseline - 10 minutes post lens settling
Title
Subjective Rating for Comfort.
Description
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Time Frame
2-weeks - During the Day
Title
Subjective Rating for Comfort.
Description
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Time Frame
2-weeks - End of Day
Title
Lens Surface Wettability
Description
Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)
Time Frame
Baseline (10 minutes post lens settling)
Title
Lens Surface Wettability
Description
Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)
Time Frame
2 weeks
Title
Surface Deposits
Description
Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = <5 deposits; 2 = >5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits >0.5mm or film > 75% of surface)
Time Frame
Baseline (10 minutes post lens settling)
Title
Surface Deposits
Description
Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = <5 deposits; 2 = >5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits >0.5mm or film > 75% of surface)
Time Frame
2-weeks
Title
Lens Handling (Ease of Insertion)
Description
Lens handling - ease of insertion of the lenses. Scale 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye.
Time Frame
2 weeks
Title
Lens Handling (Ease of Removal)
Description
Lens handling - ease of removal of the lenses. Scale 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye.
Time Frame
2 weeks
Title
Subjective Preference for Comfort.
Description
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Time Frame
Baseline - 10 minutes post lens settling
Title
Subjective Preference for Comfort.
Description
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Time Frame
2 weeks
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 spectacle lens powers between -0.50 to -6.00 diopters sphere (0.25D steps) or +1.00 to +8.00 diopters sphere (1.00D steps)
Has no more than 0.75 diopters of refractive astigmatism
Willing to wear contact lens in both eyes
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 or planning a pregnancy at the time of enrolment (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 Lin, OD PhD
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD FCO
Organizational Affiliation
University of Waterloo CCLR
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
A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks
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