Back to resultsA One-Week Crossover Dispensing Evaluation of New Daily Wear Soft Contact Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Test Contact Lens
Nelfilcon A
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Is at least 18 years of age and has full legal capacity to volunteer.
- Is no greater than 55 years of age.
- Has read and understood the information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study.
- Has spectacle cylinder ≤1.00D in both eyes.
- Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
- Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.
- Wears CLs in both eyes (monvision acceptable, but not monofit)
- Has clear corneas and no active ocular disease.
- Has not worn lenses for at least 12 hours before the examination.
- Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week
Exclusion Criteria:
- Has never worn contact lenses before.
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that will affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- Is aphakic.
- Has strabismus/amblyopia.
- Has undergone corneal refractive surgery.
- Is pregnant, lactating or planning a pregnancy.
- Is participating in any concurrent clinical or research study.
Sites / Locations
- Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Test Contact Lens
nelfilcon A lens (control)
Arm Description
Per randomized schedule, subject will wear a pair of the test lens or control lens for one week and then cross-over with the control pair for 1 week.
Per randomized schedule, subject will wear a pair of the control lens for one week and then cross-over with the test pair for 1 week.
Outcomes
Primary Outcome Measures
Lens Fit Acceptance
Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Lens Fit Acceptance
Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03306641
Brief Title
A One-Week Crossover Dispensing Evaluation of New Daily Wear Soft Contact Lenses
Official Title
A One-Week Crossover Dispensing Evaluation of Gemini Daily Wear Soft Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 28, 2017 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (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
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period 1 week compared to nelfilcon A (control).
Detailed Description
The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 1 week compared to nelfilcon A (control). The primary outcomes of interest is lens fit acceptance.
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
Model Description
This will be a double-masked, bilateral, 1-week crossover, dispensing study, comparing the test daily wear lens against nelfilcon A control lens, such that each lens type will be worn for 1 week each. Each subject will be randomized to wear either the test lenses or the control lenses as a matched pair.
Masking
ParticipantInvestigator
Masking Description
The contact lenses coding will be masked to both the investigator and subject. If standard labeling does not sufficiently mask the study material then over-labeling will be performed.
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Contact Lens
Arm Type
Active Comparator
Arm Description
Per randomized schedule, subject will wear a pair of the test lens or control lens for one week and then cross-over with the control pair for 1 week.
Arm Title
nelfilcon A lens (control)
Arm Type
Active Comparator
Arm Description
Per randomized schedule, subject will wear a pair of the control lens for one week and then cross-over with the test pair for 1 week.
Intervention Type
Device
Intervention Name(s)
Test Contact Lens
Intervention Description
Daily disposable contact lens
Intervention Type
Device
Intervention Name(s)
Nelfilcon A
Intervention Description
Focus Dailies All Day Comfort contact lens (nelfilcon A)
Primary Outcome Measure Information:
Title
Lens Fit Acceptance
Description
Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Time Frame
Baseline
Title
Lens Fit Acceptance
Description
Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Time Frame
1-Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is at least 18 years of age and has full legal capacity to volunteer.
Is no greater than 55 years of age.
Has read and understood the information consent letter.
Is willing and able to follow instructions and maintain the appointment schedule.
Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study.
Has spectacle cylinder ≤1.00D in both eyes.
Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.
Wears CLs in both eyes (monvision acceptable, but not monofit)
Has clear corneas and no active ocular disease.
Has not worn lenses for at least 12 hours before the examination.
Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week
Exclusion Criteria:
Has never worn contact lenses before.
Has any systemic disease affecting ocular health.
Is using any systemic or topical medications that will affect ocular health.
Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
Is aphakic.
Has strabismus/amblyopia.
Has undergone corneal refractive surgery.
Is pregnant, lactating or planning a pregnancy.
Is participating in any concurrent clinical or research study.
Facility Information:
Facility Name
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A One-Week Crossover Dispensing Evaluation of New Daily Wear Soft Contact Lenses
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