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The aim of this work is to investigate the clinical performance and subjective acceptance of the comfilcon A asphere contact lens when compared to single-vision spectacles in subjects who have never worn contact lenses and who use digital devices (such as phones, tablets, laptops, desktop computers) for at least 4 hours per day on at least 5 days per week.
The aim of this clinical work is to compare the clinical performance and subjective acceptance of comfilcon A asphere contact lens when compared to single-vision spectacles in subjects who use digital devices (phones, tablets, laptops, desktop computers) for at least 4 hours per day on at least 5 days per week. Subjects will be randomized to use either their habitual spectacles or the study contact lenses for two months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comfilcon A asphere | Experimental | Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. |
|
| Habitual Spectacles | Active Comparator | Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comfilcon A asphere | Device | Contact Lens |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Symptom of Burning | Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Baseline |
| Symptom of Burning | Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | 1 month |
| Symptom of Burning | Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | 2 months |
| Symptom of Itching | Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Baseline |
| Symptom of Itching | Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One Month |
| Symptom of Itching | Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Two Months |
| Symptom of Feeling of Foreign Body | Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research - The University of Manchester | Manchester | M13 9PL | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Comfilcon A Asphere | Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens |
| FG001 | Habitual Spectacles | Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| One Month |
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| ||||||||||||||||||
| Two Month |
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| ID | Title | Description |
|---|---|---|
| BG000 | Comfilcon A Asphere | Subjects were randomized to use the study contact lenses for two months. |
| BG001 | Habitual Spectacles | Subjects were randomized to wear habitual spectacles for two months. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Symptom of Burning | Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of burning was measured only for subjects who had frequency of symptom of burning on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
From baseline visit up to two months, a total of two months.
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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 | Comfilcon A Asphere | Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega | CooperVision, Inc | 925-640-2964 | javega2@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 | May 3, 2019 | Jan 15, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Spectacles | Device | Habitual spectacles |
|
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| Baseline |
| Symptom of Feeling of Foreign Body | Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One Month |
| Symptom of Feeling of Foreign Body | Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Two Months |
| Symptom of Tearing | Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Baseline |
| Symptom of Tearing | Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One Month |
| Symptom of Tearing | Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Two Months |
| Symptom of Excessive Blinking | Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Baseline |
| Symptom of Excessive Blinking | Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One Month |
| Symptom of Excessive Blinking | Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Two Months |
| Symptom of Eye Redness | Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Baseline |
| Symptom of Eye Redness | Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One Month |
| Symptom of Eye Redness | Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Two Months |
| Symptom of Eye Pain | Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Baseline |
| Symptom of Eye Pain | Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One Month |
| Symptom of Eye Pain | Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Two Months |
| Symptom of Heavy Eyelids | Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Baseline |
| Symptom of Heavy Eyelids | Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One Month |
| Symptom of Heavy Eyelids | Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Two Months |
| Symptom of Dryness | Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Baseline |
| Symptom of Dryness | Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One Month |
| Symptom of Dryness | Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Two Months |
| Symptom of Blurred Vision | Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Baseline |
| Symptom of Blurred Vision | Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One Month |
| Symptom of Blurred Vision | Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Two Months |
| Symptom of Double Vision | Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Baseline |
| Symptom of Double Vision | Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One Month |
| Symptom of Double Vision | Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Two Months |
| Symptom of Difficulty Focusing For Near Vision | Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Baseline |
| Symptom of Difficulty Focusing For Near Vision | Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One Month |
| Symptom of Difficulty Focusing For Near Vision | Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Two Months |
| Symptom of Increased Sensitivity to Light | Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Baseline |
| Symptom of Increased Sensitivity to Light | Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One Month |
| Symptom of Increased Sensitivity to Light | Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Two Months |
| Symptom of Colored Haloes Around Objects | Symptom of colored haloes around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Baseline |
| Symptom of Colored Haloes Around Objects | Symptom of colored haloes around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One Month |
| Symptom of Colored Halos Around Objects | Symptom of colored halos around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Two Months |
| Symptom of Feeling That Sight is Worsening | Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Baseline |
| Symptom of Feeling That Sight is Worsening | Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One Month |
| Symptom of Feeling That Sight is Worsening | Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Two Months |
| Symptom of Headache | Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Baseline |
| Symptom of Headache | Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One Month |
| Symptom of Headache | Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Two Months |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 |
|
Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week.
Spectacles: Habitual spectacles
|
|
| Primary | Symptom of Burning | Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One subject scores was not measured for Habitual spectacles group. Intensity of symptom of burning was measured only for subjects who had frequency of symptom of burning on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | 1 month |
|
|
|
| Primary | Symptom of Burning | Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of burning was measured only for subjects who had frequency of symptom of burning on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | 2 months |
|
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|
| Primary | Symptom of Itching | Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of itching was measured only for subjects who had frequency of itching on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Symptom of Itching | Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One subject score was not measured for Habitual spectacles group. Intensity of itching was measured only for subjects who had frequency of itching on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | One Month |
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| Primary | Symptom of Itching | Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of itching was measured only for subjects who had frequency of itching on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Two Months |
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| Primary | Symptom of Feeling of Foreign Body | Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of feeling of foreign body was measured only for subjects who had frequency of feeling of foreign body on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Symptom of Feeling of Foreign Body | Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One subject score was not measured for Habitual spectacles group. Intensity of feeling of foreign body was measured only for subjects who had frequency of feeling of foreign body on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | One Month |
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|
| Primary | Symptom of Feeling of Foreign Body | Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of feeling of foreign body was measured only for subjects who had frequency of feeling of foreign body on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Two Months |
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| Primary | Symptom of Tearing | Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of tearing was measured only for subjects who had frequency of symptom of tearing on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Symptom of Tearing | Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One subject score was not measured for Habitual spectacles group. Intensity of symptom of tearing was measured only for subjects who had frequency of symptom of tearing on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | One Month |
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| Primary | Symptom of Tearing | Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of tearing was measured only for subjects who had frequency of symptom of tearing on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Two Months |
|
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| Primary | Symptom of Excessive Blinking | Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of excessive blinking was measured only for subjects who had frequency of symptom of excessive blinking on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Symptom of Excessive Blinking | Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One subject score was not measured for Habitual spectacles group. Intensity of symptom of excessive blinking was measured only for subjects who had frequency of symptom of excessive blinking on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | One Month |
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| Primary | Symptom of Excessive Blinking | Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of excessive blinking was measured only for subjects who had frequency of symptom of excessive blinking on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Two Months |
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| Primary | Symptom of Eye Redness | Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of eye redness was measured only for subjects who had frequency of symptom of eye redness on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Symptom of Eye Redness | Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One subject score was not measured for Habitual spectacles group. Intensity of symptom of eye redness was measured only for subjects who had frequency of symptom of eye redness on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | One Month |
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| Primary | Symptom of Eye Redness | Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of eye redness was measured only for subjects who had frequency of symptom of eye redness on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Two Months |
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|
| Primary | Symptom of Eye Pain | Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of eye pain was measured only for subjects who had frequency of symptom of eye pain on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Symptom of Eye Pain | Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One subject score was not measured for Habitual spectacles group. Intensity of symptom of eye pain was measured only for subjects who had frequency of symptom of eye pain on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | One Month |
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|
| Primary | Symptom of Eye Pain | Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of eye pain was measured only for subjects who had frequency of symptom of eye pain on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Two Months |
|
|
|
| Primary | Symptom of Heavy Eyelids | Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of heavy eyelids was measured only for subjects who had frequency of symptom of heavy eyelids on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Symptom of Heavy Eyelids | Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One subject score was not measured for Habitual spectacles group. Intensity of symptom of heavy eyelids was measured only for subjects who had frequency of symptom of heavy eyelids on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | One Month |
|
|
|
| Primary | Symptom of Heavy Eyelids | Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of heavy eyelids was measured only for subjects who had frequency of symptom of heavy eyelids on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Two Months |
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|
|
| Primary | Symptom of Dryness | Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of dryness was measured only for subjects who had frequency of symptom of dryness on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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|
| Primary | Symptom of Dryness | Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One subject score was not measured for Habitual spectacles group. Intensity of symptom of dryness was measured only for subjects who had frequency of symptom of dryness on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | One Month |
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|
|
| Primary | Symptom of Dryness | Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of dryness was measured only for subjects who had frequency of symptom of dryness on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Two Months |
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| Primary | Symptom of Blurred Vision | Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of blurred vision was measured only for subjects who had frequency of symptom of blurred vision on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Symptom of Blurred Vision | Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One subject score was not measured for Habitual spectacles group. Intensity of symptom of blurred vision was measured only for subjects who had frequency of symptom of blurred vision on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | One Month |
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| Primary | Symptom of Blurred Vision | Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of blurred vision was measured only for subjects who had frequency of symptom of blurred vision on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Two Months |
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| Primary | Symptom of Double Vision | Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of double vision was measured only for subjects who had frequency of symptom of double vision on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Symptom of Double Vision | Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One subject score was not measured for Habitual spectacles group. Intensity of symptom of double vision was measured only for subjects who had frequency of symptom of double vision on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | One Month |
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| Primary | Symptom of Double Vision | Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of double vision was measured only for subjects who had frequency of symptom of double vision on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Two Months |
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| Primary | Symptom of Difficulty Focusing For Near Vision | Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of difficulty focusing for near vision was measured only for subjects who had frequency of symptom of difficulty focusing for near vision on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Symptom of Difficulty Focusing For Near Vision | Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One subject score was not measured for Habitual spectacles group. Intensity of symptom of difficulty focusing for near vision was measured only for subjects who had frequency of symptom of difficulty focusing for near vision on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | One Month |
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| Primary | Symptom of Difficulty Focusing For Near Vision | Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of difficulty focusing for near vision was measured only for subjects who had frequency of symptom of difficulty focusing for near vision on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Two Months |
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| Primary | Symptom of Increased Sensitivity to Light | Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of increased sensitivity to light was measured only for subjects who had frequency of symptom of increased sensitivity to light on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Symptom of Increased Sensitivity to Light | Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One subject score was not measured for Habitual spectacles group. Intensity of symptom of increased sensitivity to light was measured only for subjects who had frequency of symptom of increased sensitivity to light on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | One Month |
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| Primary | Symptom of Increased Sensitivity to Light | Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of increased sensitivity to light was measured only for subjects who had frequency of symptom of increased sensitivity to light on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Two Months |
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| Primary | Symptom of Colored Haloes Around Objects | Symptom of colored haloes around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of colored haloes around objects was measured only for subjects who had frequency of symptom of colored haloes around objects on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Symptom of Colored Haloes Around Objects | Symptom of colored haloes around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One subject score was not measured for Habitual spectacles group. Intensity of symptom of colored haloes around objects was measured only for subjects who had frequency of symptom of colored haloes around objects on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | One Month |
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| Primary | Symptom of Colored Halos Around Objects | Symptom of colored halos around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of colored haloes around objects was measured only for subjects who had frequency of symptom of colored haloes around objects on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Two Months |
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| Primary | Symptom of Feeling That Sight is Worsening | Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of feeling that sight is worsening was measured only for subjects who had frequency of symptom of feeling that sight is worsening on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Symptom of Feeling That Sight is Worsening | Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One subject score was not measured for Habitual spectacles group. Intensity of symptom of feeling that sight is worsening was measured only for subjects who had frequency of symptom of feeling that sight is worsening on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | One Month |
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| Primary | Symptom of Feeling That Sight is Worsening | Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of feeling that sight is worsening was measured only for subjects who had frequency of symptom of feeling that sight is worsening on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Two Months |
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| Primary | Symptom of Headache | Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of headache was measured only for subjects who had frequency of symptom of headache on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Symptom of Headache | Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | One subject score was not measured for Habitual spectacles group. Intensity of symptom of headache was measured only for subjects who had frequency of symptom of headache on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | One Month |
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| Primary | Symptom of Headache | Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense). | Intensity of symptom of headache was measured only for subjects who had frequency of symptom of headache on a scale of 1 - occasionally and 2- often/always | Posted | Mean | Standard Deviation | units on a scale | Two Months |
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| EG001 | Habitual Spectacles | Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles | 0 | 29 | 0 | 29 | 0 | 29 |
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