Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to compare the short-term clinical performance of two toric contact lenses.
The aim of this study is to evaluate the short-term clinical performance of two toric contact lenses when compared to each other after 15 minutes of daily wear each.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carole Maldonado-Codina, PhD, FBCLA | Eurolens Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research | Manchester | United Kingdom |
Forty-two participants were screened. Two participants were not eligible due to screening failure.
All the participants who were eligible in the study were included in the analysis. (n=40)
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lens 1 (Ocufilcon D) | All participants wore Lens 1 for 15 minutes (Period 1). Lens 1 (ocufilcon D): 15 minutes of daily wear |
| FG001 | Lens 2 (Somofilcon A) | All participants wore Lens 2 for 15 minutes (Period 2). Lens 2 (somofilcon A): 15 minutes of daily wear |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Lens 1 (15 Minutes) |
| |||||||||||||
| Period 2: Lens 2 (15 Minutes) |
|
40 Participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Includes all eligible 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.) | All the participants who were eligible in the study were included in the analysis. (n=40) | Posted | Mean | Standard Deviation | units on a scale | At the end of 15 minutes of daily wear |
|
Through study completion, approximately 2 hours
Not provided
Not provided
| 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 wore Lens 1 for 15 minutes (Period 1). Lens 1 (ocufilcon D): 15 minutes of daily wear |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A Vega, OD, MSc, PhD | CooperVision Inc. | 9256213761 | jvega2@coopervision.com |
Not provided
| 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 18, 2024 | Jan 30, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| NOT COMPLETED |
|
| 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 |
|
|
|
| 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.) | All the participants who were eligible in the study were included in the analysis. (n=40) | 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.) | All the participants who were eligible in the study were included in the analysis. (n=40) | Posted | Mean | Standard Deviation | units on a scale | At the end of 15 minutes of daily wear |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Lens 2 (Somofilcon A) | All participants wore Lens 2 for 15 minutes (Period 2). Lens 2 (somofilcon A): 15 minutes of daily wear | 0 | 40 | 0 | 40 | 0 | 40 |
Not provided
Not provided