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Evaluation of two contact lenses
One week dispensing, investigator-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye simultaneously.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etafilcon A | Active Comparator | Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously |
|
| Stenfilcon A | Experimental | Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etafilcon A | Device |
| ||
| Stenfilcon A |
| Measure | Description | Time Frame |
|---|---|---|
| Participant's Subjective Rating of Comfort (Questionnaire) | Participants rated their comfort of lenses by subjective questionnaire (un-annotated scale, 0-100, 0=Poor comfort/intolerable, 100=Excellent comfort/cannot be felt) Change over time measured at insertion, After settling, 12-hours, 1-week | Insertion, After Lens settling, 12-hours, 1-week |
| Participant's Subjective Rating of Dryness (Questionnaire) | Participants rated dryness of the lenses by subjective questionnaire (annotated scale, 0-100, 0=cannot be worn / extremely dry, 100=no dryness experienced at any time) Change over time measured at 12-hours, 1-week | 12-hours, 1-week |
| Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire) | Participants rated their lens handling experience for lens insertion by questionnaire (un-annotated scale, 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye) Measured at Dispensing | Dispense |
| Participant's Subjective Rating of Lens Handling for Removal (Questionnaire) | Participants rated their lens handling experience for the lens removal by questionnaire (un-annotated scale, 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye) Change over time measured at 12-hours, 1-week | 12-hours, 1-week |
| Participant's Subjective Rating of Visual Quality (Questionnaire) | Participants rated visual quality of the lenses by questionnaire (annotated scale, 0-100, 0=extremely poor vision all of the time. Cannot function, 100=excellent vision all of the time) Change over time measured at 12-hours, 1-week | 12-hours, 1-week |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy) | Investigators assigned a lens surface wettability grade by biomicroscopy assessment (grading scale, 0 to 4, 0=excellent, 4=severely reduced). Change over time measured after lens settling (insertion), after 12-hours wear on the dispense day (12-hours), after a minimum on one hour of lens wear at 1 week (1-week). | Insertion, 12 hours, 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones, PhD., FCO | Univeristy of Waterloo, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Contact Lens Research, University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada |
Two participants were determined to be ineligible at the screening visit due to their level of astigmatism
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Each participant was randomized to wear the test lens in one eye and the control lens in the other simulataneously Etafilcon A Stenfilcon A |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Participant's Subjective Rating of Comfort (Questionnaire) | Participants rated their comfort of lenses by subjective questionnaire (un-annotated scale, 0-100, 0=Poor comfort/intolerable, 100=Excellent comfort/cannot be felt) Change over time measured at insertion, After settling, 12-hours, 1-week | One participant temporarily discontinued from study after 12-hour visit. (n=43 at 1-week visit) | Posted | Mean | Standard Deviation | units on a scale | Insertion, After Lens settling, 12-hours, 1-week | eyes | eyes |
|
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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 | All Participants | Each participant was randomized to wear the test lens in one eye and the control lens in the other Etafilcon A Stenfilcon A |
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One participant temporarily discontinued after 12-hour visit. (Primary outcome 1 and 4,1-week visit, n=43)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lyndon Jones, PhD, FCO | School of Optometry, University of Waterloo | 519-888-4742 | ljones@uwaterloo.ca |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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|
| Participant's Subjective Rating of Overall Preference (Questionnaire) |
Participants rated their overall lens preference by questionnaire. (annotated scale, 0-100, scale normalized to 0=no preference, +50=strongly prefers test lens, -50=strongly prefers control lens). Change over time measured at 12-hours, 1-week |
| 12-hours, 1-week |
| Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy) | Investigators assigned an overall fit acceptance grade by biomicroscopy assessment (grading scale, 0-4, 0=very poor, 4=very good). Change over time measured at insertion, 12-hours, 1-week | Insertion, 12 hours, 1 week |
| Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen) | Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at normal lighting conditions (high illumination). (logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week. | Insertion |
| Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen) | Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at low lighting conditions (low illumination). (logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week. | Insertion, 12-hours, 1-week |
| Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with corneal staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week | Baseline, 12-hours, 1-week |
| Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with conjuncitval staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week | Baseline, 12-hours, 1-week |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A |
|
|
| Secondary | Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy) | Investigators assigned a lens surface wettability grade by biomicroscopy assessment (grading scale, 0 to 4, 0=excellent, 4=severely reduced). Change over time measured after lens settling (insertion), after 12-hours wear on the dispense day (12-hours), after a minimum on one hour of lens wear at 1 week (1-week). | Posted | Mean | Standard Deviation | units on a scale | Insertion, 12 hours, 1 week | eyes | eyes |
|
|
|
| Secondary | Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy) | Investigators assigned an overall fit acceptance grade by biomicroscopy assessment (grading scale, 0-4, 0=very poor, 4=very good). Change over time measured at insertion, 12-hours, 1-week | Posted | Mean | Standard Deviation | units on a scale | Insertion, 12 hours, 1 week | eyes | eyes |
|
|
|
| Primary | Participant's Subjective Rating of Dryness (Questionnaire) | Participants rated dryness of the lenses by subjective questionnaire (annotated scale, 0-100, 0=cannot be worn / extremely dry, 100=no dryness experienced at any time) Change over time measured at 12-hours, 1-week | Posted | Mean | Standard Deviation | units on a scale | 12-hours, 1-week | eyes | eyes |
|
|
|
| Primary | Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire) | Participants rated their lens handling experience for lens insertion by questionnaire (un-annotated scale, 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye) Measured at Dispensing | Posted | Mean | Standard Deviation | score on a scale | Dispense | eyes | eyes |
|
|
|
| Primary | Participant's Subjective Rating of Lens Handling for Removal (Questionnaire) | Participants rated their lens handling experience for the lens removal by questionnaire (un-annotated scale, 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye) Change over time measured at 12-hours, 1-week | One participant temporarily discontinued from study after 12-hour visit. (n=43 at 1-week visit) | Posted | Mean | Standard Deviation | units on a scale | 12-hours, 1-week | eyes | eyes |
|
|
|
| Primary | Participant's Subjective Rating of Visual Quality (Questionnaire) | Participants rated visual quality of the lenses by questionnaire (annotated scale, 0-100, 0=extremely poor vision all of the time. Cannot function, 100=excellent vision all of the time) Change over time measured at 12-hours, 1-week | Posted | Mean | Standard Deviation | units on a scale | 12-hours, 1-week | eyes | eyes |
|
|
|
| Primary | Participant's Subjective Rating of Overall Preference (Questionnaire) | Participants rated their overall lens preference by questionnaire. (annotated scale, 0-100, scale normalized to 0=no preference, +50=strongly prefers test lens, -50=strongly prefers control lens). Change over time measured at 12-hours, 1-week | Posted | Mean | Standard Deviation | score on a scale | 12-hours, 1-week |
|
|
|
| Secondary | Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen) | Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at normal lighting conditions (high illumination). (logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week. | Posted | Log Mean | Standard Deviation | logMAR | Insertion | eyes | eyes |
|
|
|
| Secondary | Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen) | Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at low lighting conditions (low illumination). (logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week. | Posted | Log Mean | Standard Deviation | logMAR | Insertion, 12-hours, 1-week | eyes | eyes |
|
|
|
| Secondary | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with corneal staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12-hours, 1-week | eyes | eyes |
|
|
|
| Secondary | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with conjuncitval staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12-hours, 1-week | eyes | eyes |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
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| 1-week |
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| 1-week |
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| 1-week |
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| 1-week |
|
| baseline Temporal |
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| baseline Superior |
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| baseline Inferior |
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| 12-hours Central |
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| 12-hours Nasal |
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| 12-hours Temporal |
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| 12-hours Superior |
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| 12-hours Inferior |
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| 1-week Central |
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| 1-week Nasal |
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| 1-week Temporal |
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| 1-week Superior |
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| 1-week Inferior |
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| baseline Superior |
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| baseline Inferior |
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| 12-hours Nasal |
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| 12-hours Temporal |
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| 12-hours Superior |
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| 12-hours Inferior |
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| 1-week Nasal |
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| 1-week Temporal |
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| 1-week Superior |
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| 1-week Inferior |
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