Back to resultsA 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
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:
- Is at least 18 years of age and has full legal capacity to volunteer
- Has read, fully understood and signed the information consent letter
- Currently wears or has previously worn soft contact lenses
- 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.
- Has clear corneas and no active ocular disease
- Is willing and able to follow product usage instructions and maintain the visit schedule.
Exclusion Criteria:
- Has never worn contact lenses before
- 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 any known active ocular disease and/or infection
- Has a monovision correction
- Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses
- Is aphakic
- Has undergone corneal refractive surgery
- Is pregnant or lactating, determined by self-report
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 lens
nelfilcon A lens (control)
Arm Description
Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).
Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).
Outcomes
Primary Outcome Measures
Horizontal Lens Centration Assessed in Primary Gaze
Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)
Horizontal Lens Centration Assessed in Primary Gaze
Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)
Vertical Lens Centration Assessed in Primary Gaze
Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)
Vertical Lens Centration Assessed in Primary Gaze
Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)
Lens Tightness Assessed by Push-up Test
Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)
Lens Tightness Assessed by Push-up Test
Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)
Primary Gaze Lag Assessed Observing Lens Movement in Graticule
Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)
Primary Gaze Lag Assessed Observing Lens Movement in Graticule
Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)
Horizontal Lens Lag Assessed Observing Lens Movement in Graticule
Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)
Horizontal Lens Lag Assessed Observing Lens Movement in Graticule
Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)
Overall Lens Fit Acceptance
Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Overall Lens Fit Acceptance
Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Up Gaze Lag Assessed Observing Lens Movement in Graticule
Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).
Up Gaze Lag Assessed Observing Lens Movement in Graticule
Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).
Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink
Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink
Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink
Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03235089
Brief Title
A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses
Official Title
A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 25, 2017 (Actual)
Primary Completion Date
August 3, 2017 (Actual)
Study Completion Date
August 3, 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 of 6 hours 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 6 hours compared to nelfilcon A (control). The primary outcomes of interest are lens fit and lens fit preference.
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
Model Description
This will be a non-dispensing, double-masked, contralateral study comparing test contact lens against a nelfilcon A control lens. Subjects will be randomized to wear the test lens in one eye and the control lens in the other. It is anticipated that this study will involve up to 2 scheduled visits, at Baseline (BL) and 6 hours.
Masking
ParticipantInvestigator
Masking Description
Both subject and investigator will be masked to lens type for each eye. A different investigator will select the study lenses for insertion by the subject, from those performing the assessments in order to maintain masking.
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test lens
Arm Type
Active Comparator
Arm Description
Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).
Arm Title
nelfilcon A lens (control)
Arm Type
Active Comparator
Arm Description
Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).
Intervention Type
Device
Intervention Name(s)
Test Lens
Intervention Description
Daily disposable contact lens
Intervention Type
Device
Intervention Name(s)
Control Lens
Intervention Description
Focus Dailies All Day Comfort contact lens (nelfilcon A)
Primary Outcome Measure Information:
Title
Horizontal Lens Centration Assessed in Primary Gaze
Description
Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)
Time Frame
Baseline
Title
Horizontal Lens Centration Assessed in Primary Gaze
Description
Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)
Time Frame
6-hour
Title
Vertical Lens Centration Assessed in Primary Gaze
Description
Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)
Time Frame
Baseline
Title
Vertical Lens Centration Assessed in Primary Gaze
Description
Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)
Time Frame
6-hours
Title
Lens Tightness Assessed by Push-up Test
Description
Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)
Time Frame
Baseline
Title
Lens Tightness Assessed by Push-up Test
Description
Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)
Time Frame
6-hours
Title
Primary Gaze Lag Assessed Observing Lens Movement in Graticule
Description
Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)
Time Frame
Baseline
Title
Primary Gaze Lag Assessed Observing Lens Movement in Graticule
Description
Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)
Time Frame
6 hours
Title
Horizontal Lens Lag Assessed Observing Lens Movement in Graticule
Description
Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)
Time Frame
Baseline
Title
Horizontal Lens Lag Assessed Observing Lens Movement in Graticule
Description
Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)
Time Frame
6 hours
Title
Overall Lens Fit Acceptance
Description
Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Time Frame
Baseline
Title
Overall Lens Fit Acceptance
Description
Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Time Frame
6 hours
Title
Up Gaze Lag Assessed Observing Lens Movement in Graticule
Description
Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).
Time Frame
Baseline
Title
Up Gaze Lag Assessed Observing Lens Movement in Graticule
Description
Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).
Time Frame
6 hours
Title
Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink
Description
Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink
Time Frame
Baseline
Title
Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink
Description
Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is at least 18 years of age and has full legal capacity to volunteer
Has read, fully understood and signed the information consent letter
Currently wears or has previously worn soft contact lenses
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.
Has clear corneas and no active ocular disease
Is willing and able to follow product usage instructions and maintain the visit schedule.
Exclusion Criteria:
Has never worn contact lenses before
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 any known active ocular disease and/or infection
Has a monovision correction
Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses
Is aphakic
Has undergone corneal refractive surgery
Is pregnant or lactating, determined by self-report
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 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses
We'll reach out to this number within 24 hrs