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The objective of this study is to compare the clinical performance of ProClear 1-Day versus 1-Day Acuvue Moist each for one week of daily disposable wear.
The purpose of this cross-over study is to evaluate the clinical performance of the ProClear-1 Day in comparison with 1-Day Acuvue® Moist®. In particular, the study will focus on lens wearing comfort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| omafilcon A | Active Comparator | Study participants are randomized to wear omafilcon A lenses. |
|
| etafilcon A | Active Comparator | Study participants are randomized to wear etafilcon A lenses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omafilcon A | Device | contact lens |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Comfort (Subjective Assessment) | Subjective Assessment of comfort on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel) | Baseline |
| Comfort (Subjective Assessment) | Subjective Assessment: Insertion Comfort, Comfort During Day, Comfort Prior to Removal, Comfort Overall for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel) | 1 Week |
| Hydration (Subjective Assessment) | Subjective Assessment of hydration on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic) | Baseline |
| Hydration (Subjective Assessment) | Subjective Assessment: Initial Hydration, Hydration During Day, Hydration Prior to Removal for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic) | 1 Week |
| Vision Quality (Subjective Assessment) | Subjective Assessment: Visual quality on insertion at baseline for each pair using questionnaire and rated on subjective response scale (0-10; 0= clear vision, 10=perfectly sharp) | Baseline |
| Vision Satisfaction (Subjective Assessment) | Subjective Assessment: Vision Satisfaction for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very unsatisfied, 10=very satisfied) |
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Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
Exclusion Criteria:
A person will be excluded from the study if he/she:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Siegel, OD | Sun City West Eye Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Eye Care, PLLC | Phoenix | Arizona | 85032 | United States | ||
| Lake Zurich Eye Care |
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon A First, Then Omafilcon A | Study participants are randomized to wear etafilcon A pair of study lenses then crossover to the alternate pair. |
| FG001 | Omafilcon A First, Then Etafilcon A | Study participants are randomized to wear omafilcon A pair of study lenses then crossover to the alternate pair. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (7 Days) |
|
| ||||||||||||||||||
| Second Intervention (7 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Group | Study participants are randomized to wear omafilcon A or etafilcon A pair of study lenses then crossover to the alternate pair. |
| 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 | Comfort (Subjective Assessment) | Subjective Assessment of comfort on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
From dispense up to one week for each 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 | Omafilcon A | Study participants are randomized to wear omafilcon A lenses. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager Global Medical/Scientific Affairs | CooperVision, Inc. | 925-621-3761 | javega@coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| etafilcon A | Device | contact lens |
|
|
| 1 Week |
| Dryness (Subjective Assessment) | Subjective Assessment: Dryness During Day, Dryness Prior to Removal, Overall Dryness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dry, 10=no dryness) | 1 Week |
| Handling (Subjective Assessment) | Subjective Assessment: Handling on Insertion and Removal, Overall Handling for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very difficult, 10=very easy) | 1 Week |
| Eye Whiteness/Redness (Subjective Assessment) | Subjective Assessment: Eye Whiteness/Redness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= significant redness, 10=totally white) | 1 Week |
| Overall Sensation of Smoothness (Subjective Assessment) | Subjective Assessment: Overall sensation of smoothness at 1 week wear for each pair when asked "How would you rate the overall sensation of smoothness (deposit resistance) of the first study lenses, over the last week of wear?" (Likert 1-5; 1=excellent, 2=good, 3=average, 4=below average, 5=poor) | 1 Week |
| Overall Satisfaction for Lens | Subjective Assessment: Satisfaction overall at 1 Week wear for each pair when asked "Overall, how satisfied was the subject with the study lenses, during the last week, with regards to: Overall?" (Likert 1-4; 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied) | 1 Week |
| Lake Zurich |
| Illinois |
| 60047 |
| United States |
| Drs. Quinn, Foster & Assoc. | Athens | Ohio | 45701 | United States |
| Vision Professionals | New Albany | Ohio | 43054 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Comfort (Subjective Assessment) | Subjective Assessment: Insertion Comfort, Comfort During Day, Comfort Prior to Removal, Comfort Overall for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel) | One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1. | Posted | Mean | Standard Deviation | units on a scale | 1 Week |
|
|
|
| Primary | Hydration (Subjective Assessment) | Subjective Assessment of hydration on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Hydration (Subjective Assessment) | Subjective Assessment: Initial Hydration, Hydration During Day, Hydration Prior to Removal for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic) | One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1. | Posted | Mean | Standard Deviation | units on a scale | 1 Week |
|
|
|
| Primary | Vision Quality (Subjective Assessment) | Subjective Assessment: Visual quality on insertion at baseline for each pair using questionnaire and rated on subjective response scale (0-10; 0= clear vision, 10=perfectly sharp) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Vision Satisfaction (Subjective Assessment) | Subjective Assessment: Vision Satisfaction for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very unsatisfied, 10=very satisfied) | One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1. | Posted | Mean | Standard Deviation | units on a scale | 1 Week |
|
|
|
| Primary | Dryness (Subjective Assessment) | Subjective Assessment: Dryness During Day, Dryness Prior to Removal, Overall Dryness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dry, 10=no dryness) | One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1. | Posted | Mean | Standard Deviation | units on a scale | 1 Week |
|
|
|
| Primary | Handling (Subjective Assessment) | Subjective Assessment: Handling on Insertion and Removal, Overall Handling for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very difficult, 10=very easy) | One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1. | Posted | Mean | Standard Deviation | units on a scale | 1 Week |
|
|
|
| Primary | Eye Whiteness/Redness (Subjective Assessment) | Subjective Assessment: Eye Whiteness/Redness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= significant redness, 10=totally white) | One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1. | Posted | Mean | Standard Deviation | units on a scale | 1 Week |
|
|
|
| Primary | Overall Sensation of Smoothness (Subjective Assessment) | Subjective Assessment: Overall sensation of smoothness at 1 week wear for each pair when asked "How would you rate the overall sensation of smoothness (deposit resistance) of the first study lenses, over the last week of wear?" (Likert 1-5; 1=excellent, 2=good, 3=average, 4=below average, 5=poor) | One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1. | Posted | Number | participants | 1 Week |
|
|
|
| Primary | Overall Satisfaction for Lens | Subjective Assessment: Satisfaction overall at 1 Week wear for each pair when asked "Overall, how satisfied was the subject with the study lenses, during the last week, with regards to: Overall?" (Likert 1-4; 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied) | One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1. | Posted | Number | participants | 1 Week |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Etafilcon A | Study participants are randomized to wear etafilcon A lenses. | 0 | 43 | 0 | 43 |
The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
| Comfort Prior to Removal |
|
| Comfort Overall |
|
| Hydration Prior to Removal |
|
| Overall Dryness |
|
| Average |
|
| Below Average |
|
| Poor |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|