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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test lens | Active Comparator | 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). |
|
| nelfilcon A lens (control) | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Lens | Device | Daily disposable contact lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline |
| 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) | 6-hour |
| 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) | Baseline |
| 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) | 6-hours |
| 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) | Baseline |
| 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) | 6-hours |
| Primary Gaze Lag Assessed Observing Lens Movement in Graticule |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University | Bloomington | Indiana | 47405 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test 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. Test Lens: Daily disposable contact lens |
| FG001 | Nelfilcon A Lens (Control) | 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. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Subjects were randomized to wear test lens in one eye and control lens in other eye for 6 hours. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | millimeters | Baseline | Eyes | Eyes |
|
From dispense up to 6 hours on each type of study lenses
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test 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. Test Lens: Daily disposable contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lee Hall, BSc, PhD, MCOptom, FBCLA | CooperVision, Inc | 925 251 6684 | lhall@coopervision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2017 | Jul 31, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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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.
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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.
| Control Lens |
| Device |
Focus Dailies All Day Comfort contact lens (nelfilcon A) |
|
Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps) |
| Baseline |
| Primary Gaze Lag Assessed Observing Lens Movement in Graticule | Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps) | 6 hours |
| Horizontal Lens Lag Assessed Observing Lens Movement in Graticule | Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps) | Baseline |
| Horizontal Lens Lag Assessed Observing Lens Movement in Graticule | Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps) | 6 hours |
| 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) | Baseline |
| 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) | 6 hours |
| 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). | Baseline |
| 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). | 6 hours |
| 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 | Baseline |
| 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 | 6 hours |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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) | Posted | Mean | Standard Deviation | millimeters | 6-hour | Eyes | Eyes |
|
|
|
| Primary | 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) | Posted | Mean | Standard Deviation | millimeters | Baseline | Eyes | Eyes |
|
|
|
| Primary | 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) | Posted | Mean | Standard Deviation | millimeters | 6-hours | Eyes | Eyes |
|
|
|
| Primary | 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline | Eyes | Eyes |
|
|
|
| Primary | 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) | Posted | Mean | Standard Deviation | units on a scale | 6-hours | Eyes | Eyes |
|
|
|
| Primary | Primary Gaze Lag Assessed Observing Lens Movement in Graticule | Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps) | Posted | Mean | Standard Deviation | millimeters | Baseline | Eyes | Eyes |
|
|
|
| Primary | Primary Gaze Lag Assessed Observing Lens Movement in Graticule | Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps) | Posted | Mean | Standard Deviation | millimeters | 6 hours | Eyes | Eyes |
|
|
|
| Primary | Horizontal Lens Lag Assessed Observing Lens Movement in Graticule | Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps) | Posted | Mean | Standard Deviation | millimeters | Baseline | Eyes | Eyes |
|
|
|
| Primary | Horizontal Lens Lag Assessed Observing Lens Movement in Graticule | Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps) | Posted | Mean | Standard Deviation | millimeters | 6 hours | Eyes | Eyes |
|
|
|
| Primary | 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline | Eyes | Eyes |
|
|
|
| Primary | 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) | Posted | Mean | Standard Deviation | units on a scale | 6 hours | Eyes | Eyes |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | millimeters | Baseline | Eyes | Eyes |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | millimeters | 6 hours | Eyes | Eyes |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | millimeters | Baseline | Eyes | Eyes |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | millimeters | 6 hours | Eyes | Eyes |
|
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|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Nelfilcon A Lens ( Control) | 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. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A) | 0 | 28 | 0 | 28 | 0 | 28 |
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