Back to resultsComparison of New Contact Lens With Current Marketed Lens
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phoebe test lens
stenfilcon 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:
- Between and 18 and 35 years of age and has full legal capacity to volunteer
- Has had a self-reported oculo-visual examination in the last two years
- 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 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
- Has a Contact Lens Refraction between -1.00D and -6.00D
- Cylinder power ≤ -0.75DC in Spherical Cylindrical Refraction
- Currently wears soft contact lenses
- Is willing to wear lenses for a minimal of 8 hours a day and everyday during the course of the study
- Has clear corneas and no active ocular disease
- Has not worn lenses for at least 12 hours before the first visit
Exclusion Criteria
A person will be excluded from the study if he/she:
- Has never worn contact lenses before
- Is wearing Monovision modality
- 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 undergone corneal refractive surgery
- Is participating in any other type of eye related clinical or research study
Sites / Locations
- Clinical Optical Research Lab (CORL)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Test lens
stenfilcon A lens (control)
Arm Description
Subjects randomized to wear pair of test lens either first or second
Subjects randomized to wear pair of control lens either first or second
Outcomes
Primary Outcome Measures
Corneal Staining Extent
Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a 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).
Corneal Staining Extent
Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a 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).
Conjunctival Staining Score
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Conjunctival Staining Score
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Palpebral Hyperemia on Upper Lid
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Palpebral Hyperemia on Upper Lid
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Palpebral Hyperemia on Lower Lid
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Palpebral Hyperemia on Lower Lid
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Palpebral Roughness Grade - Upper Lid
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Palpebral Roughness Grade - Upper Lid
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Palpebral Roughness Grade - Lower Lid
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Palpebral Roughness Grade - Lower Lid
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Secondary Outcome Measures
Distance Visual Acuity
Distance visual acuity recorded in logMAR.
Distance Visual Acuity
Distance visual acuity recorded in logMAR.
Near Visual Acuity
Near visual acuity recorded in logMAR
Near Visual Acuity
Near visual acuity recorded in logMAR
Vision Quality Rating
Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)
Vision Quality Rating
Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03360110
Brief Title
Comparison of New Contact Lens With Current Marketed Lens
Official Title
Clinical Validation Study of Phoebe Lens
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
December 15, 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
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.
Detailed Description
Evaluate the clinical performance of its Phoebe contact lenses (Test) compared to the commercially available MyDay contact lenses (Control).
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
Masking Description
Double masked (participant, investigator)
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test lens
Arm Type
Active Comparator
Arm Description
Subjects randomized to wear pair of test lens either first or second
Arm Title
stenfilcon A lens (control)
Arm Type
Active Comparator
Arm Description
Subjects randomized to wear pair of control lens either first or second
Intervention Type
Device
Intervention Name(s)
Phoebe test lens
Other Intervention Name(s)
Test Lens, Phoebe Contact Lens
Intervention Description
Daily disposable contact lens
Intervention Type
Device
Intervention Name(s)
stenfilcon A lens (control)
Other Intervention Name(s)
MyDay daily disposable contact lens
Intervention Description
Daily disposable contact lens
Primary Outcome Measure Information:
Title
Corneal Staining Extent
Description
Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a 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).
Time Frame
Baseline
Title
Corneal Staining Extent
Description
Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a 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).
Time Frame
Day 3
Title
Conjunctival Staining Score
Description
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Time Frame
Baseline
Title
Conjunctival Staining Score
Description
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Time Frame
Day 3
Title
Palpebral Hyperemia on Upper Lid
Description
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Time Frame
Baseline
Title
Palpebral Hyperemia on Upper Lid
Description
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Time Frame
Day 3
Title
Palpebral Hyperemia on Lower Lid
Description
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Time Frame
Baseline
Title
Palpebral Hyperemia on Lower Lid
Description
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Time Frame
Day 3
Title
Palpebral Roughness Grade - Upper Lid
Description
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Time Frame
Baseline
Title
Palpebral Roughness Grade - Upper Lid
Description
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Time Frame
Day 3
Title
Palpebral Roughness Grade - Lower Lid
Description
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Time Frame
Baseline
Title
Palpebral Roughness Grade - Lower Lid
Description
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
Distance Visual Acuity
Description
Distance visual acuity recorded in logMAR.
Time Frame
Baseline (at lens dispense)
Title
Distance Visual Acuity
Description
Distance visual acuity recorded in logMAR.
Time Frame
Day 3
Title
Near Visual Acuity
Description
Near visual acuity recorded in logMAR
Time Frame
Baseline (at dispense)
Title
Near Visual Acuity
Description
Near visual acuity recorded in logMAR
Time Frame
Day 3
Title
Vision Quality Rating
Description
Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)
Time Frame
Baseline (at dispense)
Title
Vision Quality Rating
Description
Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)
Time Frame
Day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
A person is eligible for inclusion in the study if he/she:
Between and 18 and 35 years of age and has full legal capacity to volunteer
Has had a self-reported oculo-visual examination in the last two years
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 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
Has a Contact Lens Refraction between -1.00D and -6.00D
Cylinder power ≤ -0.75DC in Spherical Cylindrical Refraction
Currently wears soft contact lenses
Is willing to wear lenses for a minimal of 8 hours a day and everyday during the course of the study
Has clear corneas and no active ocular disease
Has not worn lenses for at least 12 hours before the first visit
Exclusion Criteria
A person will be excluded from the study if he/she:
Has never worn contact lenses before
Is wearing Monovision modality
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 undergone corneal refractive surgery
Is participating in any other type of eye related clinical or research study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter S Kolbaum, O.D., Ph.D., FAAO, FBCLA
Organizational Affiliation
Clinical Optics Research Lab (CORL), Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Optical Research Lab (CORL)
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
Comparison of New Contact Lens With Current Marketed Lens
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