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The study objective was to gather short-term clinical performance data for two soft contact lenses.
The aim of this subject-masked, non-randomized, controlled non-dispensing study was to evaluate the short-term clinical performance of a monthly sphere contact lens when compared to a daily disposable contact lens after 15 minutes of daily wear each.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens 1 | Experimental | All participants wore Lens 1 for 15 minutes (Period 1) |
|
| Lens 2 | Experimental | All participants wore Lens 2 for 15 minutes (Period 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens 1 (monthly replacement) | Device | Monthly replacement spherical silicone hydrogel contact lens for 15 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Overall Score | Subjective overall score was assessed using 0-100 visual analogue scale, where 0=Extremely poor, cannot use lenses and 100=Excellent, highly impressed with these lenses overall | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Comfort | Subjective comfort score was assessed using 0-100 visual analogue scale, where 0=Causes pain, cannot be tolerated and 100=Excellent, cannot be felt | 15 minutes |
| Subjective Vision |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Morgan, PhD, MCOptom | Eurolens Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research | Manchester | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens 1 (Monthly Replacement) | All participants wore Lens 1 for 15 minutes (Period 1) |
| FG001 | Lens 2 (Daily Disposable) | All participants wore Lens 2 for 15 minutes (Period 2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Lens 1, 15 Minutes |
| |||||||||||||
| Period 2: Lens 2, 15 Minutes |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All participants who participated in the clinical trial. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data is presented as stratified by the sex of the participant |
| 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 | Subjective Overall Score | Subjective overall score was assessed using 0-100 visual analogue scale, where 0=Extremely poor, cannot use lenses and 100=Excellent, highly impressed with these lenses overall | One participant was excluded from data analysis due to issues during lens application | Posted | Mean | Standard Deviation | score on a scale | 15 minutes |
|
The duration of the clinical trial, approximately 1.5 hours
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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 | Lens 1 | All participants that received Lens 1 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| José A. Vega OD, MSc, FAAO | CooperVision, Inc. | +19256213761 | jvega2@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 | Nov 4, 2022 | Nov 14, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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All participants received Lens 1 and then Lens 2 in fixed-sequence order.
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| Lens 2 (daily disposable) | Device | Daily disposable spherical silicone hydrogel contact lens for 15 minutes |
|
Subjective vision score was assessed using a 0-100 visual analogue scale, where 0=Unacceptable, lens cannot be worn and 100=Excellent, unaware of any visual loss
| 15 minutes |
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| 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Subjective Comfort | Subjective comfort score was assessed using 0-100 visual analogue scale, where 0=Causes pain, cannot be tolerated and 100=Excellent, cannot be felt | One participant was excluded from data analysis due to issues during lens application | Posted | Mean | Standard Deviation | score on a scale | 15 minutes |
|
|
|
| Secondary | Subjective Vision | Subjective vision score was assessed using a 0-100 visual analogue scale, where 0=Unacceptable, lens cannot be worn and 100=Excellent, unaware of any visual loss | One participant was excluded from data analysis due to issues during lens application | Posted | Mean | Standard Deviation | score on a scale | 15 minutes |
|
|
|
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Lens 2 | All participants that received Lens 2 | 0 | 45 | 0 | 45 | 0 | 45 |
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