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| Name | Class |
|---|---|
| Foresight Regulatory Strategies, Inc. | INDUSTRY |
| Visioncare Research Ltd. | OTHER |
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The objective of this study is to evaluate the clinical performance of two silicone-hydrogel contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| galyfilcon A/comfilcon A | Active Comparator | galyfilcon A first, comfilcon A second |
|
| comfilcon A/galyfilcon A | Active Comparator | comfilcon A first, galyfilcon A second |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| galyfilcon A | Device | galyfilcon A |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Comfort | >0 = comfortable, <0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. | 1-week, 2- weeks |
| Comfort Symptoms | A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. >0 = comfortable, <0 = uncomfortable | 1-week, 2-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Corneal Staining | Measured for 5 zones of the cornea (superior, nasal, central, inferior, temporal)on a 0 to 3 grade scale (NEI 0-3 scale). Grade 0 = Normal/ grade 1 = mild, superficial stippling/ grade 2 = moderate, punctate staining including superficial abrasion of the cornea/ grade 3 = severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
The subject is a rigid gas permeable (RGP) or daily disposable lens wearer.
The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids or associated structures.
The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjogren's syndrome, type II diabetes, etc.)
Slit lamp findings that would contraindicate contact lens wear such as:
A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
A known history of corneal hypoesthesia (reduced corneal sensitivity).
Contact lens snellen visual acuities (VA) worse than 20/30.
Aphakia, keratoconus or a highly irregular cornea.
Current pregnancy or lactation (to the best of the subject's knowledge)
Any active participation in another clinical study at any time during this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Galyfilcon A / Comfilcon A | galyfilcon A contact lenses first period, comfilcon a contact lenses second period |
| FG001 | Comfilcon A / Galyfilcon A | comfilcon A contact lenses first period, galyfilcon A contact lenses second period |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
|
| |||||||||||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Completed Population | Includes subjects randomized to galyfilcon A/comfilcon A and comfilcon A/galyfilcon A and that completed the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Comfort | >0 = comfortable, <0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. | Only participants who completed the study per protocol (n=78) | Posted | Least Squares Mean | Standard Error | combined score | 1-week, 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 | Galyfilcon A / Comfilcon A | galyfilcon A contact lenses first period, comfilcon a contact lenses second period |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kurt Moody, OD FAAO | Vistakon | 904-443-3088 |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| comfilcon A |
| Device |
comfilcon A |
|
| Ineligible |
|
| Protocol Violation |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Overall Corneal Staining | Measured for 5 zones of the cornea (superior, nasal, central, inferior, temporal)on a 0 to 3 grade scale (NEI 0-3 scale). Grade 0 = Normal/ grade 1 = mild, superficial stippling/ grade 2 = moderate, punctate staining including superficial abrasion of the cornea/ grade 3 = severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion. | Only the participants who completed the study per protocol (n=78) | Posted | Least Squares Mean | Standard Error | combined score | 2 weeks |
|
|
|
|
| Primary | Comfort Symptoms | A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. >0 = comfortable, <0 = uncomfortable | Only participants who completed the study per protocol (n=78) | Posted | Least Squares Mean | Standard Error | score | 1-week, 2-weeks |
|
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Comfilcon A / Galyfilcon A | comfilcon A contact lenses first period, galyfilcon A contact lenses second period | 0 | 46 | 0 | 46 |
The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.