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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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CL discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society in their seminal report on contact lens (CL) discomfort as a condition that results in "episodic or persistent adverse ocular sensation related to lens wear, either with or without visual disturbance resulting from reduced compatibility between the CL and the environment, which can lead to decreased wearing time and discontinuation of CL wear." A recent review by Pucker and Tichenor found that CL discomfort was the top reason for established CL wears to cease wearing CLs. This same review alarmingly found that the frequency of CL dropout was about 20% across the many studies aimed at evaluating this condition, which is surprising given the introduction of better soft CL materials and daily disposable CLs over the past 20 plus years.
Dailies Total1 (DT1), which is a relatively new daily disposable CL, is a commonly used trouble shooting CL for patients who have failed with other CLs because DT1 utilizes advanced material technology that is specifically aimed at improving CL comfort. While DT1 is commonly used in these struggling patients, the literature currently lacks a targeted study aimed at understanding the frequency of successfully refitting CL dropouts into this advanced CL. Thus, the purpose of this study is to determine the frequency that past CL wearers who failed because of dryness or CL discomfort who can comfortable wear DT1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dailies Total1 | Experimental | All participants will be asked to wear Dailies Total1 for the duration of this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DT1 Sphere Contact Lenses | Device | Devices: Dailies Total 1 Sphere Contact Lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Contact Lenses Comfort Scores | The median visual analog scale (VAS) scores at the 1-month visit (-50 to +50 scale with scores greater than 0 being comfortable). | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Likert Questionnaire | Number of participants who were likely to refer the study contact lens to a friend. | One Month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35213 | United States | ||
| Kannarr Eye Care |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dailies Total1 | All participants will be asked to wear Dailies Total1 for the duration of this study. DT1 Sphere Contact Lenses: Devices: Dailies Total 1 Sphere Contact Lenses |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dailies Total1 | All participants will be asked to wear Dailies Total1 for the duration of this study. DT1 Sphere Contact Lenses: Devices: Dailies Total 1 Sphere Contact Lenses |
| 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, 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) Contact Lenses Comfort Scores | The median visual analog scale (VAS) scores at the 1-month visit (-50 to +50 scale with scores greater than 0 being comfortable). | Subjects were recruited via clinic records, email and fliers, and they were pre-screened with an Institutional Review Board (IRB)- approved qualification questionnaire over the telephone. Adult, 18- to 40-year-old (inclusive), past CL wearers who had a Logarithm of the Minimum Angle of Resolution (logMAR) best-corrected visual acuity of 0.00 or better were recruited. Subjects were required to have worn CLs for at least 1year in the past. | Posted | Median | Inter-Quartile Range | Score on a scale | 1 month |
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Adverse events were observed over a 6 month time period.
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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 | Dailies Total1 | All participants will be asked to wear Dailies Total1 for the duration of this study. DT1 Sphere Contact Lenses: Devices: Dailies Total 1 Sphere Contact Lenses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Pucker, OD, PhD | University of Alabama at Birmingham | 920-579-2900 | andrewpucker@hotmail.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 13, 2021 | Aug 19, 2024 | Prot_SAP_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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All participants will be assigned to wear Dailies Total 1 Sphere contact lenses. They will report to 3 in person visits over the course of one month.
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| Pittsburg |
| Kansas |
| 66762 |
| United States |
| ProCare Vision Center | Granville | Ohio | 43023 | United States |
| The Southern College of Optometry | Memphis | Tennessee | 38104 | United States |
| Participants |
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| Age, Continuous | Median | Inter-Quartile Range | 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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| Secondary | Likert Questionnaire | Number of participants who were likely to refer the study contact lens to a friend. | All subjects who completed the 1 month visit. | Posted | Count of Participants | Participants | One Month |
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|
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| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
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