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| Name | Class |
|---|---|
| Centre for Ocular Research & Education, Canada | OTHER |
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To evaluate and compare the performance of two monthly replacement multifocal contact lenses in existing wearers.
This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type was worn for approximately 4-6 weeks: the lens prescription of each lens type was optimized after 3-10 days wearing experience, prior to starting a 1-month (28-32 days) wear period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Lens, then Test Lens | Experimental | Participants wore Control Lens for 1 month, then the Test Lens for 1 month |
|
| Test Lens, then Control Lens | Experimental | Participants wore the Test Lens for 1 month, then the Control Lens for 1 month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Lens (comfilcon A) | Device | Multifocal monthly replacement contact lens for 1 month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Handling for Insertion | Subjective rating collected in office using a 0-100 scale, where 0=Very difficult and 100=Very easy. The participant rated the study lens considering a typical day in the last 1 month of wear. | 1 month |
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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 spherical multifocal soft contact lenses, for the past 3 months minimum:
Had refractive astigmatism no higher than -0.75DC;
Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;
Could be fit and achieve binocular distance vision of at least 20/30 Snellen which participants also deem to be 'acceptable', with the available study lens parameters (Distance sphere +4 to -6; near addition as per study design).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Sacco | Sacco Eye Group | Principal Investigator |
| David Wilkinson | Spadina Optometry | Principal Investigator |
| Katherine Bickle | ProCare Vision Center | Principal Investigator |
| Dustin Gardner | New Bremen EyeCare | Principal Investigator |
| Gina Wesley | Complete Eye Care of Medina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complete Eye Care of Medina | Medina | Minnesota | 55364 | United States | ||
| Sacco Eye Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Lens, Then Test Lens | Participants wore the Control Lens for 1 month, then the Test Lens for 1 month |
| FG001 | Test Lens, Then Control Lens | Participants wore the Test Lens for 1 month, then the Control Lens for 1 month |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: First Intervention |
| |||||||||||||
| Period 2: Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Participants who completed all 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 Insertion | Subjective rating collected in office using a 0-100 scale, where 0=Very difficult and 100=Very easy. The participant rated the study lens considering a typical day in the last 1 month of wear. | Posted | Mean | Standard Deviation | score on a scale | 1 month |
|
Length of study, approximately 3 months
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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 | All participants that received the Control Lens. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small lymph cysts | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| José A. Vega | CooperVision Inc. | +1 (925) 621-3761 | 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 | Dec 12, 2023 | Dec 26, 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 (lehfilcon A) | Device | Multifocal monthly replacement contact lens for 1 month |
|
| Vestal |
| New York |
| 13850 |
| United States |
| ProCare Vision Center | Granville | Ohio | 43023 | United States |
| New Bremen EyeCare | New Bremen | Ohio | 45869 | United States |
| Spadina Optometry | Toronto | Ontario | M5V 3E7 | Canada |
| 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 |
|
| Units | Counts |
|---|
| Participants |
|
|
| 60 |
| 0 |
| 60 |
| 4 |
| 60 |
| EG001 | Test Lens | All participants that received the Test Lens. | 0 | 59 | 0 | 59 | 4 | 59 |
| Subconjunctival hemorrhage | Eye disorders | Systematic Assessment |
|
| Eye floaters | Eye disorders | Systematic Assessment |
|
| Respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Stomach distress | Gastrointestinal disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
|
| Primary care provider intervention | Surgical and medical procedures | Systematic Assessment | Per primary care providers recommendation participant stopped the medication Vyvanse. |
|
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