Back to resultsA Dispensing Clinical Trial of Test Contact Lens Against Marketed Contact Lens
Primary Purpose
Myopia
Status
Completed
Phase
Locations
United States
Study Type
Interventional
Intervention
Test lens
Control lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Has had a self-reported oculo-visual examination in the last two years.
- Is at least 18 years of age and has full legal capacity to volunteer.
- 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 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- Currently wears soft contact lenses.
- Requires spectacle lens powers between -0.75 to -6.50 diopters sphere (0.25D steps).
- Has no more than 0.75 diopters of refractive astigmatism.
- Has clear corneas and no active ocular disease.
- Has not worn lenses for at least 12 hours before the examination.
- Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit
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 undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
- Known allergy to a product used in this study (ex. Shellfish allergy)
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
Sites / Locations
- Clinical Research Center, University of California, Berkeley
- Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test lens
Control lens
Arm Description
Subjects wearing the test contact lens either as first or second pair during the cross-over study.
Subjects wearing the control contact lens either as first or second pair during the cross-over study.
Outcomes
Primary Outcome Measures
Lens Surface Wettability
Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
Lens Surface Wettability
Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
Lens Surface Wettability
Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
Lens Surface Deposits
Lens surface deposits was measured on a Scale 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 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface)
Lens Surface Deposits
Lens surface deposits was measured on a Scale 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 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface).
Lens Surface Deposits
Lens surface deposits was measured on a Scale 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 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface)
Overall Lens Fit Acceptance
Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)
Overall Lens Fit Acceptance
Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)
Overall Lens Fit Acceptance
Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm)
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm)
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm)
Secondary Outcome Measures
Bulbar Conjunctiva Hyperaemia
Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Bulbar Conjunctiva Hyperaemia
Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Bulbar Conjunctiva Hyperaemia
Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Limbal Conjunctiva Hyperaemia
Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Limbal Conjunctiva Hyperaemia
Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Limbal Conjunctiva Hyperaemia
Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03499067
Brief Title
A Dispensing Clinical Trial of Test Contact Lens Against Marketed Contact Lens
Official Title
A Dispensing Clinical Trial of Invigor I Lens Against Clariti Lens
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 11, 2018 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
4. Oversight
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed lens (control), when worn on a daily basis for 1 month.
Detailed Description
Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed silicone- hydrogel contact lens (control), when worn on a daily basis for 1 month.
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
Interventional Study Model
Crossover Assignment
Model Description
Each subject will be randomized to wear the test or control contact lens for 1 month and then crossed-over to wear the other contact lens for 1 month.
Masking
ParticipantInvestigator
Masking Description
This will be a double-masked study in which both participant and investigator will be masked.
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test lens
Arm Type
Experimental
Arm Description
Subjects wearing the test contact lens either as first or second pair during the cross-over study.
Arm Title
Control lens
Arm Type
Active Comparator
Arm Description
Subjects wearing the control contact lens either as first or second pair during the cross-over study.
Intervention Type
Device
Intervention Name(s)
Test lens
Other Intervention Name(s)
Invigor I lens
Intervention Description
Contact lens
Intervention Type
Device
Intervention Name(s)
Control lens
Other Intervention Name(s)
Clariti lens
Intervention Description
Contact lens
Primary Outcome Measure Information:
Title
Lens Surface Wettability
Description
Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
Time Frame
Baseline
Title
Lens Surface Wettability
Description
Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
Time Frame
2-weeks
Title
Lens Surface Wettability
Description
Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
Time Frame
4-weeks
Title
Lens Surface Deposits
Description
Lens surface deposits was measured on a Scale 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 0.5mm 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
Title
Lens Surface Deposits
Description
Lens surface deposits was measured on a Scale 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 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface).
Time Frame
2-weeks
Title
Lens Surface Deposits
Description
Lens surface deposits was measured on a Scale 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 0.5mm 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
Title
Overall Lens Fit Acceptance
Description
Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)
Time Frame
Baseline
Title
Overall Lens Fit Acceptance
Description
Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)
Time Frame
2-Weeks
Title
Overall Lens Fit Acceptance
Description
Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)
Time Frame
4-Weeks
Title
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Description
Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm)
Time Frame
Baseline
Title
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Description
Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm)
Time Frame
2-weeks
Title
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Description
Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm)
Time Frame
4-weeks
Secondary Outcome Measure Information:
Title
Bulbar Conjunctiva Hyperaemia
Description
Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time Frame
Baseline
Title
Bulbar Conjunctiva Hyperaemia
Description
Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time Frame
2-weeks
Title
Bulbar Conjunctiva Hyperaemia
Description
Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time Frame
4-weeks
Title
Limbal Conjunctiva Hyperaemia
Description
Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time Frame
Baseline
Title
Limbal Conjunctiva Hyperaemia
Description
Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time Frame
2-weeks
Title
Limbal Conjunctiva Hyperaemia
Description
Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time Frame
4-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has had a self-reported oculo-visual examination in the last two years.
Is at least 18 years of age and has full legal capacity to volunteer.
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 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
Currently wears soft contact lenses.
Requires spectacle lens powers between -0.75 to -6.50 diopters sphere (0.25D steps).
Has no more than 0.75 diopters of refractive astigmatism.
Has clear corneas and no active ocular disease.
Has not worn lenses for at least 12 hours before the examination.
Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit
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 undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.
Known allergy to a product used in this study (ex. Shellfish allergy)
Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
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
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 Dispensing Clinical Trial of Test Contact Lens Against Marketed Contact Lens
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