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| Name | Class |
|---|---|
| Centre for Ocular Research & Education, Canada | OTHER |
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The objective of the study was to compare the lens performance of two daily disposable multifocal contact lenses.
This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type was worn for approximately 3-4 weeks: the lens prescription of each lens type was optimized after a 3-8 days wearing experience, then participants began a 2 week (14-21 day) wear period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Lens, then Test Lens | Experimental | Participants wore Control Lens for 2 weeks, then crossed over to Test Lens for 2 weeks. |
|
| Test Lens, then Control Lens | Experimental | Participants wore Test Lens for 2 weeks, then crossed over to Control Lens for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Lens (stenfilcon A) | Device | Daily Disposable Multifocal Contact Lens for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Handling for Removal | Subjective rating for ease of removal of the study lenses on a 0-100 scale, where 0=Very difficult and 100=Very easy. Collected once at the end of 2 weeks of wear. | 2 Weeks |
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Inclusion Criteria:
Were at least 42 years of age and had full legal capacity to volunteer;
Had read and signed an information consent letter;
Self-reported having had a full eye examination in the previous two years;
Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week
Were willing and able to follow instructions and maintain the appointment schedule;
Habitually wore multifocal soft contact lenses, for the past 3 months minimum
Had refractive astigmatism no higher than -0.75DC in each eye;
Were presbyopic and required a reading addition of at least +0.75D and no more than +2.50D;
Could be fit and achieved binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deemed to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS, near addition as per study design)
Exclusion Criteria:
A person was excluded from the study if they:
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| Name | Affiliation | Role |
|---|---|---|
| David Wilkinson | Spadina Optometry | Principal Investigator |
| Ashley Tucker | Bellaire Family Eye Care | Principal Investigator |
| Fiona Soong | Eyes on Sheppard Clinic | Principal Investigator |
| Andrew Sacco | Sacco Eye Group PLLC | Principal Investigator |
| Shane Foster | Athens Eye Care - Dr. Shane Foster & Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sacco Eye Group PLLC | Vestal | New York | 13850 | United States | ||
| Athens Eye Care- Dr. Shane Foster & Associates |
Of the 60 participants screened, 1 exited the study prior to randomization due to screen failure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Lens, Then Test Lens | Participants first wore Control Lens for 2 weeks, then crossed over to wear Test Lens for 2 weeks |
| FG001 | Test Lens, Then Control Lens | Participants first wore Test Lens for 2 weeks, then crossed over to wear Control Lens for 2 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: First Intervention, 2 Weeks |
|
| |||||||||||||||||||||
| Period 2: Second Intervention, 2 Weeks |
|
All participants who were screened for the study. Baseline data was collected from participants not considered Enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Study Population | All participants that attended one or more study visits |
| 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 | Lens Handling for Removal | Subjective rating for ease of removal of the study lenses on a 0-100 scale, where 0=Very difficult and 100=Very easy. Collected once at the end of 2 weeks of wear. | Participants that completed all study visits. | Posted | Mean | Standard Deviation | score on a scale | 2 Weeks |
|
Duration of the study, approximately 6 weeks (prescription optimization for 3-8 days, then test lens wear for 2 weeks each)
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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 | Control Lens | Participants that received the Control Lens during either the first or second period of the study |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stye | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| José A. Vega OD, PhD, 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 16, 2022 | Jun 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Test Lens (senofilcon A) | Device | Daily Disposable Multifocal Contact Lens for 2 weeks |
|
| Athens |
| Ohio |
| 45701 |
| United States |
| Bellaire Family Eye Care | Bellaire | Texas | 77401 | United States |
| Eyes on Sheppard Clinic | Toronto | Ontario | M2N 3A1 | Canada |
| Spadina Optometry | Toronto | Ontario | M5V 3E7 | Canada |
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| 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 |
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| 2 |
| 57 |
| EG001 | Test Lens | Participants that received the Test Lens during either the first or second period of the study | 0 | 58 | 0 | 58 | 3 | 58 |
| Eyelid myokymia | Eye disorders | Systematic Assessment |
|
| Dose increase | Surgical and medical procedures | Systematic Assessment | Urologist increased dosage of current medication. Non-ocular and unrelated to study lens. |
|
| Botox Injection Forehead | Surgical and medical procedures | Systematic Assessment |
|
| Vertigo | Nervous system disorders | Systematic Assessment |
|
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