Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Manchester | OTHER |
This study seeks to evaluate the clinical and subjective performance of a new daily disposable soft contact lens.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Habitual silicone hydrogel | Active Comparator | Habitual contact lens wear. |
|
| narafilcon A | Experimental | Silicone hydrogel daily disposable contact lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Habitual Silicone Hydrogel Contact Lens | Device | contact lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Limbal Hyperemia | Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames. | At 2 weeks and 4 weeks |
| Lens Comfort | Rating of lens comfort by rating agreement to the following statement: "The lenses I am wearing are comfortable." Rating using the following scale: 1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames. | At 3,7,10,13,17,21,24, and 27 days |
| Upper Lid Margin Staining | Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames. | At 2 weeks and 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Tarsal Roughness | Measures the amount of roughness to the tissue of the inside upper and lower eyelid on a scale of 0 to 100 with 0=none and 100=severe. The analysis is the average grade over all time frames. | At 2 weeks and 4 weeks |
| Tarsal Hyperemia |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Contact Lens Research | Waterloo | Ontario | N2L 3G1 | Canada |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Habitual Silicone Hydrogel | Habitual contact lens wear. |
| FG001 | Narafilcon A | Silicone hydrogel daily disposable contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Habitual Silicone Hydrogel | Habitual contact lens wear. |
| BG001 | Narafilcon A | Silicone hydrogel daily disposable contact lens |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Includes all subjects that completed the study. |
| 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 | Limbal Hyperemia | Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames. | The analysis includes all subjects that completed the study. | Posted | Least Squares Mean | Standard Error | units on a scale | At 2 weeks and 4 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Habitual Silicone Hydrogel | Habitual contact lens wear. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kurt Moody, O.D. FAOO | Vistakon | 904-443-3088 |
Not provided
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| narafilcon A |
| Device |
contact lens |
|
Measures the amount of redness to the tissue of the inside upper and lower eyelid using a 0 to 100 scale with 0=none and 100=severe.
| At 2 weeks and 4 weeks. |
| Corneal Staining | A measure of corneal abrasion using a 0 to 100 scale with 0=none, 25=micropunctate, 50=macropunctate, 75=coalescence, 100=patch. The analysis is the average grade over all time frames. | At 2 weeks and 4 weeks. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Gender | Includes all subjects that completed the study. | Number | participants |
|
| Region of Enrollment | Includes all subjects that completed the study. | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Lens Comfort | Rating of lens comfort by rating agreement to the following statement: "The lenses I am wearing are comfortable." Rating using the following scale: 1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames. | The analysis includes all subjects that completed the study. | Posted | Least Squares Mean | Standard Error | units on a scale | At 3,7,10,13,17,21,24, and 27 days |
|
|
|
|
| Primary | Upper Lid Margin Staining | Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames. | The analysis includes all subjects that completed the study. | Posted | Least Squares Mean | Standard Error | units on a scale. | At 2 weeks and 4 weeks. |
|
|
|
|
| Secondary | Tarsal Roughness | Measures the amount of roughness to the tissue of the inside upper and lower eyelid on a scale of 0 to 100 with 0=none and 100=severe. The analysis is the average grade over all time frames. | The analysis includes all subjects that completed the study. | Posted | Least Squares Mean | Standard Error | units on a scale | At 2 weeks and 4 weeks |
|
|
|
|
| Secondary | Tarsal Hyperemia | Measures the amount of redness to the tissue of the inside upper and lower eyelid using a 0 to 100 scale with 0=none and 100=severe. | The analysis includes all subjects that completed the study. | Posted | Least Squares Mean | Standard Error | units on a scale | At 2 weeks and 4 weeks. |
|
|
|
|
| Secondary | Corneal Staining | A measure of corneal abrasion using a 0 to 100 scale with 0=none, 25=micropunctate, 50=macropunctate, 75=coalescence, 100=patch. The analysis is the average grade over all time frames. | Posted | Least Squares Mean | Standard Error | units on a scale | At 2 weeks and 4 weeks. |
|
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Narafilcon A | Silicone hydrogel daily disposable contact lens | 0 | 40 | 0 | 40 |
The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.