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The aim of this study is to compare the short-term clinical performance of two soft contact lenses.
The aim of this study is to evaluate the short-term clinical performance of two soft contact lenses when compared to each other after 15 minutes of daily wear each.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens 1 (ocufilcon D) | Experimental | All participants will wear lens 1 for 15 minutes (Period 1). |
|
| Lens 2 (somofilcon A) | Experimental | All participants will wear lens 2 for 15 minutes (Period 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens 1 (ocufilcon D) | Device | 15 minutes of daily wear |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Overall Score | The primary outcome measure for this study is the subjective overall score on a scale of 0-100 (0= Extremely poor, unmanageable, cannot use lenses, 100= Excellent, highly impressed with these lenses overall). | At the end of 15 minutes of daily wear |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Vision | The secondary outcome measure for this study is the subjective vision on a scale of 0-100 (0= Extremely poor, intolerable, lenses cannot be worn, 100= Excellent, unaware of any visual loss). | At the end of 15 minutes of daily wear |
| Subjective Comfort |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carole Maldonado-Codina, PhD, FBCLA | Eurolens Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research | Manchester | United Kingdom |
Fifty Two participants were screened. All the participants who were eligible (n=50) in the study were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens 1 (Ocufilcon D) Then Lens 2 (Somofilcon A) | All participants received Lens 1 (ocufilcon D) for 15 minutes in Period 1, followed by Lens 2 (somofilcon A) for 15 minutes in Period 2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Lens 1 (ocufilcon D) 15minutes |
|
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| Period 2: Lens 2 (somoflcon A) 15minutes |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Includes all study participants |
| 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 | Subjective Overall Score | The primary outcome measure for this study is the subjective overall score on a scale of 0-100 (0= Extremely poor, unmanageable, cannot use lenses, 100= Excellent, highly impressed with these lenses overall). | Posted | Mean | Standard Deviation | Units on Scale | At the end of 15 minutes of daily wear |
|
Through study completion (single visit, approximately 30 minutes)
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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 (Ocufilcon D) | All participants will wear lens 1 for 15 minutes (Period 1). Lens 1 (ocufilcon D): 15 minutes of daily wear |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose Vega | CooperVision, Inc. | 9256213761 | 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 | Sep 13, 2024 | May 11, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006956 | Hyperopia |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lens 2 (somofilcon A) |
| Device |
15 minutes of daily wear |
|
The secondary outcome measure for this study is the subjective comfort on a scale of 0-100 (0= Extremely uncomfortable, causes pain, cannot be tolerated, 100= Excellent, cannot be felt). |
| At the end of 15 minutes of daily wear |
| 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 Vision | The secondary outcome measure for this study is the subjective vision on a scale of 0-100 (0= Extremely poor, intolerable, lenses cannot be worn, 100= Excellent, unaware of any visual loss). | Posted | Mean | Standard Deviation | units on a scale | At the end of 15 minutes of daily wear |
|
|
|
| Secondary | Subjective Comfort | The secondary outcome measure for this study is the subjective comfort on a scale of 0-100 (0= Extremely uncomfortable, causes pain, cannot be tolerated, 100= Excellent, cannot be felt). | Posted | Mean | Standard Deviation | units on a scale | At the end of 15 minutes of daily wear |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Lens 2 (Somofilcon A) | All participants will wear lens 2 for 15 minutes (Period 2). Lens 2 (somofilcon A): 15 minutes of daily wear | 0 | 50 | 0 | 50 | 0 | 50 |
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