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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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The purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs.
Contact lens (CL) wearers frequently face eye discomfort symptoms, especially towards the end of the wear day. This burdensome discomfort can unfortunately cause patients to remove their CLs before their desired wear time. While comfortable wear times vary from patient to patient, Terry et al. has suggested that patients should be able to comfortably wear their CLs for at least 12 hours per day for at least 6 days per week. Nevertheless, the literature currently lacks sufficient data to comment fully on the full day wear experience, which for many patients may be 16 or more hours per day, especially if they have demanding careers. One CL that has the potential to allow for all day comfort is the Total30 Sphere CLs, which is a new water gradient, monthly CL aimed at delivering all day comfort and visual performance. Thus, the purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs. These data are not only important for judging the performance of Total30 Sphere CLs, but they will provide some of the first insights into the full day CL wearing experience over one month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total30 Sphere Contact Lenses | Experimental | All qualified participants will be refit into Total30 Sphere contact lenses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total30 Sphere Contact Lenses | Device | Participants will be refit into Total30 Sphere contact lenses and followed for 1 month. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Ocular Comfort | A visual analog scale (VAS) was used to compare end of day ocular comfort at 16 hours of contact lens wear over the 1 month study (0 to 100 scale with 100 being best). | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew D Pucker, OD, MS, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35213 | United States | ||
| University of Alabama at Birmingham |
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| ID | Title | Description |
|---|---|---|
| FG000 | Total30 Sphere Contact Lenses | All qualified participants will be refit into Total30 Sphere contact lenses. Total30 Sphere Contact Lenses: Participants will be refit into Total30 Sphere contact lenses and followed for 1 month. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Adult, 18- to 45-year-old, contact lens wearers who had 20/20 visual acuity or better and who were minimally symptomatic contact lens wearers were recruited. This was a single arm study, so no baseline analyses were performed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Total30 Sphere Contact Lenses | All qualified participants will be refit into Total30 Sphere contact lenses. Total30 Sphere Contact Lenses: Participants will be refit into Total30 Sphere contact lenses and followed for 1 month. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Visual Analog Scale (VAS) Ocular Comfort | A visual analog scale (VAS) was used to compare end of day ocular comfort at 16 hours of contact lens wear over the 1 month study (0 to 100 scale with 100 being best). | Total30 Contact Lens Wearing Participants | Posted | Mean | Standard Deviation | units on a scale | 1 month |
|
|
Each participant was enrolled in this clinical trial for 1 month. The trial consisted of 3 in person visits (baseline, 1 week, and 1 month).
Subjects were seen by an eye care professional three different times during the 1 month study. They were put through standard eye exam measures and contact lenses were thoroughly checked for comfort prior to distribution.
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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 | Total30 Sphere Contact Lenses | All qualified participants will be refit into Total30 Sphere contact lenses. Total30 Sphere Contact Lenses: Participants will be refit into Total30 Sphere contact lenses and followed for 1 month. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew D. Pucker, OD, PhD | University of Alabama at Birmingham | 1-920-579-2900 | apucker@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 17, 2022 | Nov 17, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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This prospective, one-month, three-visit study will refit all participants into Total30 Sphere contact lenses.
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| Birmingham |
| Alabama |
| 35294 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Participants |
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| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
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