Back to resultsA Contralateral Dispensing Clinical Trial of Study Test Sapphire Lens Against Enfilcon A Silicone Hydrogel Lens
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sapphire Lens
enfilcon A
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
Subjects will only be eligible for the study if:
- Is at least 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 -6.50 diopters sphere;
- 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:
Subjects will not be eligible to take part in the study if:
- 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; * 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
- Clinical Research Center, University of California, Berkeley
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sapphire lens
enfilcon A
Arm Description
Each subject will be randomized to wear the test lens on one eye and control lens on one eye.
Each subject will be randomized to wear the test lens on one eye and control lens on one eye.
Outcomes
Primary Outcome Measures
Subjective Ratings for Comfort After Lens Insertion
Subjective ratings for comfort on a 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
Subjective Ratings for Comfort After Lens Insertion
Subjective ratings for comfort on a 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
Percentage of Participants With a Lens Preference Based on Subjective Comfort
Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference
Percentage of Participants With a Lens Preference Based on Subjective Comfort
Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference
Lens Wettability
Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)
Lens Wettability
Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)
Lens Surface Deposition
Lens Surface Deposit was assessed on a scale of 0-4 (0-4, 0.25 steps)(0- Clean , no deposits, 1- 5 or less small deposits (<0.1mm), 2- >5 deposits of <0.1mm size or film covering 25-50% of surface, 3 - Deposits of between 0.1 and 0.5amm or film covering 50-75% of surface, 4- Deposits of 0.5mm or larger or film covering more than 75% of surface)
Lens Surface Deposition
Lens Surface Deposit was assessed on a scale of 0-4 (0-4, 0.25 steps)(0- Clean , no deposits, 1- 5 or less small deposits (<0.1mm), 2- >5 deposits of <0.1mm size or film covering 25-50% of surface, 3 - Deposits of between 0.1 and 0.5amm or film covering 50-75% of surface, 4- Deposits of 0.5mm or larger or film covering more than 75% of surface)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02518490
Brief Title
A Contralateral Dispensing Clinical Trial of Study Test Sapphire Lens Against Enfilcon A Silicone Hydrogel Lens
Official Title
A Contralateral Dispensing Clinical Trial of Study Test Sapphire Lens Against Enfilcon A Silicone Hydrogel Lens
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
October 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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This was be a randomized, contralateral, double-masked, dispensing study comparing the Study test lens against the control lens over one month of lens wear.
The study results were not used for design validation of test lens.
Detailed Description
Subjects were randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses were used in a daily wear modality for one month.
The study results were not used for design validation of test lens.
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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sapphire lens
Arm Type
Experimental
Arm Description
Each subject will be randomized to wear the test lens on one eye and control lens on one eye.
Arm Title
enfilcon A
Arm Type
Active Comparator
Arm Description
Each subject will be randomized to wear the test lens on one eye and control lens on one eye.
Intervention Type
Device
Intervention Name(s)
Sapphire Lens
Intervention Description
Each subject will be randomized to wear the test lens on one eye and control lens on one eye.
Intervention Type
Device
Intervention Name(s)
enfilcon A
Intervention Description
Each subject will be randomized to wear the test lens on one eye and control lens on one eye.
Primary Outcome Measure Information:
Title
Subjective Ratings for Comfort After Lens Insertion
Description
Subjective ratings for comfort on a 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 Frame
Baseline (5 minutes post lens dispensing)
Title
Subjective Ratings for Comfort After Lens Insertion
Description
Subjective ratings for comfort on a 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 Frame
4 weeks
Title
Percentage of Participants With a Lens Preference Based on Subjective Comfort
Description
Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference
Time Frame
Baseline (5 minutes post lens dispensing)
Title
Percentage of Participants With a Lens Preference Based on Subjective Comfort
Description
Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference
Time Frame
4 weeks
Title
Lens Wettability
Description
Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)
Time Frame
Baseline (5 minutes post lens dispensing)
Title
Lens Wettability
Description
Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)
Time Frame
4 weeks
Title
Lens Surface Deposition
Description
Lens Surface Deposit was assessed on a scale of 0-4 (0-4, 0.25 steps)(0- Clean , no deposits, 1- 5 or less small deposits (<0.1mm), 2- >5 deposits of <0.1mm size or film covering 25-50% of surface, 3 - Deposits of between 0.1 and 0.5amm or film covering 50-75% of surface, 4- Deposits of 0.5mm or larger or film covering more than 75% of surface)
Time Frame
Baseline (5 minutes post lens dispensing)
Title
Lens Surface Deposition
Description
Lens Surface Deposit was assessed on a scale of 0-4 (0-4, 0.25 steps)(0- Clean , no deposits, 1- 5 or less small deposits (<0.1mm), 2- >5 deposits of <0.1mm size or film covering 25-50% of surface, 3 - Deposits of between 0.1 and 0.5amm or film covering 50-75% of surface, 4- Deposits of 0.5mm or larger or film covering more than 75% of surface)
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects will only be eligible for the study if:
Is at least 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 -6.50 diopters sphere;
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:
Subjects will not be eligible to take part in the study if:
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; * 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
Meng Lin
Organizational Affiliation
Clinical Research Center, University of California, Berkeley
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
12. IPD Sharing Statement
Learn more about this trial
A Contralateral Dispensing Clinical Trial of Study Test Sapphire Lens Against Enfilcon A Silicone Hydrogel Lens
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