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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 clinical performance of two monthly toric silicone hydrogel contact lenses in habitual wearers, when worn for 1-month each.
This study was a prospective, bilateral eye, subjected-masked, randomized, 1-month cross-over, daily-wear design involving two different silicone hydrogel toric lens types. Each lens type will be worn bilaterally for approximately one month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens A, Then Lens B | Experimental | Participants will wear Lens A for one month and then crossover to Lens B for one month. |
|
| Lens B, Then Lens A | Experimental | Participants will wear Lens B for one month and then crossover to Lens A for one month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens A (comfilcon A toric lens) | Device | One month wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Handling on Removal | Lens Handling on Removal, using a 0-100 scale (0= very difficult, 100=very easy). | At the end of one month of wear |
| Measure | Description | Time Frame |
|---|---|---|
| Distance Visual Acuity | Distance Visual Acuity, using Snellen converted to logMAR. | At the end of one month of wear |
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Inclusion Criteria:
Is between 18 and 39 years of age (inclusive) and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Self-reports having a full eye examination in the previous two years;
Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;
Is willing and able to follow instructions and maintain the appointment schedule;
Habitually wears of toric soft contact lenses binocularly.
No more than 1/3 of the participants should be wearing daily disposable soft toric lenses;
the remaining 2/3+ of the participants must be planned frequent replacement soft toric lens wearers as follows:
Has refractive astigmatism of at least -0.75DC but no more than -2.75DC in each eye that is correctable with a soft toric lens with a cylinder power of no greater than -2.25DC;
Is ammetropic and requires a spectacle spherical component of +8.00 to -10.00D inclusively;
Can be fit and achieve binocular distance vision of at least 20/32 Snellen with the available lens parameters
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Sacco | Sacco Eye Group | Principal Investigator |
| David Wilkinson | Spadina Optometry | Principal Investigator |
| Fiona Soong | Eyes on Sheppard Clinic | Principal Investigator |
| Katherine Bickle | ProCare Vision Center | Principal Investigator |
| Shane R. Kannarr | Kannarr Eye Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States | ||
| Sacco Eye Group |
There were 50 participants enrolled and 1 was discontinued due to lost to follow-up prior to the first lens dispense.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens A, Then Lens B | Participants will wear Lens A for one month and then crossover to Lens B for one month. Lens A (comfilcon A toric lens): One month wear Lens B (lehfilcon A toric lens): One month wear |
| FG001 | Lens B, Then Lens A |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention, 1 Month |
|
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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 | May 31, 2023 |
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| Lens B (lehfilcon A toric lens) | Device | One month wear |
|
| Vestal |
| New York |
| 13850 |
| United States |
| ProCare Vision Center | Granville | Ohio | 43023 | United States |
| Eyes on Sheppard Clinic | Toronto | Ontario | M2N 3A4 | Canada |
| Spadina Optometry | Toronto | Ontario | M5V 3E7 | Canada |
Participants will wear Lens B for one month and then crossover to Lens A for one month. Lens A (comfilcon A toric lens): One month wear Lens B (lehfilcon A toric lens): One month wear |
| COMPLETED |
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| NOT COMPLETED |
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| Second Intervention, 1 Month |
|
Analysis Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Analysis Population | All participants who completed study. (Total Study Population n=49) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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 |
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| 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 on Removal | Lens Handling on Removal, using a 0-100 scale (0= very difficult, 100=very easy). | Posted | Mean | Standard Deviation | units on a scale | At the end of one month of wear |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Distance Visual Acuity | Distance Visual Acuity, using Snellen converted to logMAR. | Posted | Mean | Standard Deviation | logMAR | At the end of one month of wear |
|
|
Duration of the study, approximately 2 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 | Lens A | Participants that received Lens A during either the first or second period of the study. | 0 | 49 | 0 | 49 | 5 | 49 |
| EG001 | Lens B | Participants that received Lens B during either the first or second period of the study. | 0 | 49 | 0 | 49 | 4 | 49 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inflammated skin due to eye make-up spread in eye | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Red Eye (No Discomfort) | Eye disorders | Systematic Assessment |
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| Botox Injection | General disorders | Systematic Assessment |
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| Gum Graft Surgery | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Insomnolence | General disorders | Systematic Assessment |
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| Sinus Infection | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Stuffy nose and sneezing | General disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega,OD,MSc,FAAO | CooperVision | 925-621-3761 | jvega2@coopervision.com |
| Feb 12, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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