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The objective of the study is to compare the clinical performance of two different daily disposable, SiHy toric contact lens types, Lens A and Lens B, in existing soft lens wearers when worn for one week each.
This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable toric lens types. Each lens type will be worn for approximately one week, during which participants record their subjective lens-wear experience.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens A | Experimental | daily disposable soft contact lens - test lens Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. |
|
| Lens B | Active Comparator | daily disposable soft contact lens - control lens Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens A | Device | daily disposable soft contact lens - test lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Ease of Lens Handling | Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy) | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m) | Baseline - after lenses have settled for 10 minutes |
| Visual Acuity | Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones, PhD, FCOptom | Centre for Ocular Research and Education | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden Optometric Group | Whittier | California | 90606 | United States | ||
| Golden Vision |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens A, Then Lens B | Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens Lens B: daily disposable soft contact lens - control lens |
| FG001 | Lens B, Then Lens A | Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. Lens A: daily disposable soft contact lens - test lens Lens B: daily disposable soft contact lens - control lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | daily disposable soft contact lens - test lens Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens Lens B: daily disposable soft contact lens - control lens |
| 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 | Overall Ease of Lens Handling | Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy) | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
From dispense up to 1 week on each study lenses for a total of 2 weeks
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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 | Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| inferior single corneal peripheral ulcer | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, O.D., MSc, FAAO | Coopervision | 9256213761 | 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 | Feb 10, 2021 | Jan 18, 2022 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lens B |
| Device |
daily disposable soft contact lens - control lens |
|
| 1 week |
| Sarasota |
| Florida |
| 34237 |
| United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Athens Eye Care | Athens | Ohio | 45701 | United States |
| NOT COMPLETED |
|
| Participants |
|
| 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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| Region of Enrollment | Number | participants |
|
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| Secondary | Visual Acuity | Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m) | Posted | Mean | Standard Deviation | logMAR | Baseline - after lenses have settled for 10 minutes |
|
|
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| Secondary | Visual Acuity | Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m) | Posted | Mean | Standard Deviation | logMAR | 1 week |
|
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|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Lens B | Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. Lens B: daily disposable soft contact lens - control lens | 0 | 48 | 0 | 48 | 1 | 48 |
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