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This study aims to compare the short-term clinical performance of the two study contact lenses.
The aim of this study is to evaluate the short-term clinical performance of two multifocal toric soft contact lenses after 15 minutes of daily wear each.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens A (omafilcon A) | Experimental | All participants will wear lens A for 15 minutes (Period 1). |
|
| Lens B (comfilcon A) | Experimental | All participants will wear lens B for 15 minutes (Period 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens A (omafilcon A) | Device | 15 minutes of daily wear. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Distance Vision | Subjective Distance Vision will be measured on a scale from 0-100 (Where 0= Extremely poor. Intolerable. Lenses cannot be worn. 100= Excellent. Unaware of any visual loss). | At the end of 15 minutes of daily wear |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carole Maldonado-Codina, PhD,MCOptom | Eurolens Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Manchester | Manchester | United Kingdom |
Forty participants were screened. Of those, four participants were ineligible and excluded from the study. Thirty-six participants were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens A (Omafilcon A) | All participants wore Lens A for 15 minutes (Period 1). Lens A (omafilcon A): 15 minutes of daily wear. |
| FG001 | Lens B (Comfilcon A) | All participants wore Lens B for 15 minutes (Period 2). Lens B (comfilcon A): 15 minutes of daily wear. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Lens A (15 Minutes) |
|
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| Period 2: Lens B (15 Minutes) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Includes all enrolled 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 Distance Vision | Subjective Distance Vision will be measured on a scale from 0-100 (Where 0= Extremely poor. Intolerable. Lenses cannot be worn. 100= Excellent. Unaware of any visual loss). | All participants that completed the study. | Posted | Mean | Standard Deviation | units on a scale | At the end of 15 minutes of daily wear |
|
Through study completion, approximately sixteen weeks.
The Adverse Events cannot be attributed to one intervention or the other. Therefore, an additional Arm/Group was added to report these Adverse Events (i.e., a total of 3 Arms/Groups).
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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 A (Omafilcon A) | Participants that received Lens A | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suspect vitreous detachment | Eye disorders | Systematic Assessment | Unrelated to study lenses. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, OD, MSc, PhD | CooperVision, Inc. | 925-621-3761 | javega@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 | Mar 11, 2024 | May 29, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lens B (comfilcon A) |
| Device |
15 minutes of daily wear. |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Four participants were ineligible, of which two were ineligible due to astigmatism in their left eye, one had poor visual acuity in their right eye and one did not require a reading add. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Lens B (Comfilcon A) | Participants that received Lens B | 0 | 34 | 0 | 34 | 0 | 34 |
| EG002 | No Intervention | All Study Participants | 0 | 36 | 0 | 36 | 2 | 36 |
|
| Sub-conjunctival haemorrhage | Eye disorders | Systematic Assessment | Unrelated to study lenses. |
|
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