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The main objective of the study was to evaluate the clinical acceptance of soft contact lenses for Myopia control.
Participants were randomized to wear each study contact lenses for 10 days with investigator and participant masking. The participants who are not contact lens wearer at enrollment wore single vision contact lenses for two weeks during the pre-investigation phase to get adapted to contact lens wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omafilcon A Control Lens first, then Omafilcon A Test Lens 1, then Omafilcon A Test Lens 2 | Experimental | Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types. |
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| Omafilcon A Test Lens 2 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 1 | Experimental | Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types. |
|
| Omafilcon A Test Lens 1 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 2 | Experimental | Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omafilcon A control lens | Device | Participants were randomized to wear omafilcon A control soft contact lens for 10 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Vision Satisfaction | Overall vision satisfaction recorded on a visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy) | 10 days |
| Habitual Daily Wearing Time | Habitual daily wearing time in hours | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Visual acuity measured using logMAR | 10 days |
| Overall Visual Satisfaction During the Use of iPad With White Screen | Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocular Technology Group - International | London | SW1E 6AU | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omafilcon A Control Lens First, Then Omafilcon A Test Lens 1, Then Omafilcon A Test Lens 2 | Participants first wore omafilcon A control lens first, followed by the other 2 study contact lenses in a randomized order. Each study lens was worn for 10 days. |
| FG001 | Omafilcon A Test Lens 2 First, Then Omafilcon A Control Lens , Then Omafilcon A Test Lens 1 | Participants first wore omafilcon A test lens 1, followed by the other 2 study contact lenses in a randomized order. Each study lens was worn for 10 days. |
| FG002 | Omafilcon A Test Lens 1 First, Then Omafilcon A Control Lens , Then Omafilcon A Test Lens 2 | Participants first wore omafilcon A test lens 2, followed by the other 2 study contact lenses in a randomized order. Each study lens was worn for 10 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Nineteen total participants were analyzed out of the 20 participants who completed the study. One participant was not included in the analysis because of the compliance issue (Did not complete required hours with lens).
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Nineteen total participants were analyzed out of the 20 participants who completed the study. |
| 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 | Overall Vision Satisfaction | Overall vision satisfaction recorded on a visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy) | 19 total participants were analyzed out of the 20 participants. One participant was not included in the study because of the compliance issue (Did not complete required hours with lens). | Posted | Mean | Standard Deviation | units on a scale | 10 days |
|
Duration of all three study lens wear for approximately 30 days.
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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 Control Lens | Participants wore omafilcon A Control Lens during the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Product Issues | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Chamberlain | Coopervision | 925-251-6682 | PChamberlain@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 | Sep 3, 2020 | Jun 14, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| omafilcon A test lens 1 | Device | Participants were randomized to wear omafilcon A test soft contact lens 1 for 10 days. |
|
| omafilcon A test lens 2 | Device | Participants were randomized to wear omafilcon A test soft contact lens 2 for 10 days. |
|
| 10 days |
| Visual Satisfaction During the Use of Ipad With White Screen- How Clear is the Close-up Vision. | Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Clear at All, 100 - Very Clear) | 10 Days |
| Visual Satisfaction During the Use of iPad With Black Screen- How Happy the Vision is. | Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy) | 10 Days |
| Visual Satisfaction During the Use of Ipad With Black Screen- How Clear is the Close-up the Vision is. | Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Clear at All, 100 - Very Clear) | 10 Days |
| 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 |
|
| OG002 | Omafilcon A Test Lens 2 | Participants wore omafilcon A Test Lens 2 during the study. |
|
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| Primary | Habitual Daily Wearing Time | Habitual daily wearing time in hours | 19 total participants were analyzed out of the 20 participants. One participant was not included in the study because of the compliance issue (Did not complete required hours with lens). | Posted | Mean | Standard Deviation | Hours/Day | 10 days |
|
|
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| Secondary | Visual Acuity | Visual acuity measured using logMAR | 19 total participants were analyzed out of the 20 participants. One participant was not included in the study because of the compliance issue (Did not complete required hours with lens). | Posted | Mean | Standard Deviation | logMAR | 10 days |
|
|
|
| Secondary | Overall Visual Satisfaction During the Use of iPad With White Screen | Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy) | 19 total participants were analyzed out of the 20 participants. One participant was not included in the study because of the compliance issue (Did not complete required hours with lens). | Posted | Mean | Standard Deviation | units on a scale | 10 days |
|
|
|
| Secondary | Visual Satisfaction During the Use of Ipad With White Screen- How Clear is the Close-up Vision. | Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Clear at All, 100 - Very Clear) | 19 total participants were analyzed out of the 20 participants. One participant was not included in the study because of the compliance issue (Did not complete required hours with lens). | Posted | Mean | Standard Deviation | units on a scale | 10 Days |
|
|
|
| Secondary | Visual Satisfaction During the Use of iPad With Black Screen- How Happy the Vision is. | Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy) | 19 total participants were analyzed out of the 20 participants. One participant was not included in the study because of the compliance issue (Did not complete required hours with lens). | Posted | Mean | Standard Deviation | units on a scale | 10 Days |
|
|
|
| Secondary | Visual Satisfaction During the Use of Ipad With Black Screen- How Clear is the Close-up the Vision is. | Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Clear at All, 100 - Very Clear) | 19 total participants were analyzed out of the 20 participants. One participant was not included in the study because of the compliance issue (Did not complete required hours with lens). | Posted | Mean | Standard Deviation | units on a scale | 10 Days |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 2 |
| 19 |
| EG001 | Omafilcon A Test Lens 1 | Participants wore omafilcon A Test Lens 1 during the study. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG002 | Omafilcon A Test Lens 2 | Participants wore omafilcon A Test Lens 2 during the study. | 0 | 19 | 0 | 19 | 0 | 19 |
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