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The purpose of this study is to evaluate and compare the clinical performance of two toric contact lenses amongst 110 subjects, 2-week, single masked (subject), daily wear, randomized, bilateral, crossover study; 4 weeks duration. Hypotheses include equal or better performance of the test lens over the control lenses for comfort, vision, and toric fit characteristics as well as corneal integrity
Up to 7 sites in the US will participate. Each investigator will have both test and control lens types. There will be a maximum of 6 scheduled visits:
Visit 1: Habitual lens evaluation / Baseline / Trial fitting Visit 2: Dispensing (to be combined with Visit 1 where possible), Visit 3: Questionnaire only (no exam) 7 days (±2) after dispensing, Visit 4: 2 week follow-up 14 days (±3) after dispensing, and dispense second lens type, Visit 5: Questionnaire only (no exam) 7 days (±2) after 2nd lens dispense, Visit 6: 2 week follow-up 14 days (±3) after 2nd lens dispense
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| senofilcon A | Experimental | senofilcon A toric daily wear contact lenses |
|
| alphafilcon A | Active Comparator | alphafilcon A toric daily wear contact lenses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A toric | Device | silicone hydrogel toric lens, 2 wk replacement, daily wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Orientation Within 5 Degrees | Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion. | 1 minute after insertion |
| Lens Stability | Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation. | 10-15 minutes after insertion |
| Subjective Lens Comfort | A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. >0=comfortable, <0=uncomfortable. | 1 and 2 weeks |
| Subjective Vision | A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive vision outcomes. The analysis shows the difference in outcome between the test and control. >0=satisfactory vision, <0=unsatisfactory vision. | 1 and 2 weeks |
| Overall Corneal Staining | Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe. | after 2 weeks use |
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Inclusion Criteria:
Exclusion Criteria:
Presbyopic or has the need for a near add for reading.
Previous refractive surgery; current or previous orthokeratology treatment.
Aphakia, keratoconus or a highly irregular cornea.
The presence of ocular or systemic disease or has the need for medication (ocular or systemic) which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (e.g., Sjögren's syndrome, type II diabetes, allergies).
A known history of corneal hypoesthesia (reduced corneal sensitivity.)
Anterior uveitis or iritis (past or present).
A history of recurrent erosions, corneal infiltrates corneal ulcer or fungal infections.
Clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations or infections of the eye, eyelids, or associated structures.
Slit lamp findings that would contraindicate contact lens wear such as:
Current pregnancy or lactation (to the best of the subject's knowledge).
Actively participating in another clinical study at any time during this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ted Brink and Associates | Jacksonville | Florida | 32256 | United States | ||
| Eola Eyes |
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A Toric / Alphafilcon A Toric | senofilcon A toric work bilaterally during first 2-week period, alphafilcon A toric work bilaterally during second 2-week period. |
| FG001 | Alphafilcon A Toric / Senofilcon A Toric | alphafilcon A toric work bilaterally during first 2-week period, senofilcon A toric work bilaterally during second 2-week period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 - 2 Weeks |
|
| |||||||||||||||||||||
| Period 2 - 2 Weeks |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Completed Participants |
| 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 Orientation Within 5 Degrees | Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion. | Subjects/eyes that completed the study were analyzed. A total of 168 eyes/84 subjects were analyzed. | Posted | Number | Eyes | 1 minute after insertion |
|
|
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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 | Senofilcon A Toric / Alphafilcon A Toric | senofilcon A toric work bilaterally during first 2-week period, alphafilcon A toric work bilaterally during second 2-week period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kurt Moody, OD | Vistakon | 904-443-3088 |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| alphafilcon A toric | Device | hydrogel toric lens, 2 wk replacement, daily wear |
|
|
| Orlando |
| Florida |
| 32801 |
| United States |
| Clayton Eye Center | Morrow | Georgia | 30260 | United States |
| The Koetting Associates Inc. | St Louis | Missouri | 63144 | United States |
| Southern Eyes | Concord | North Carolina | 28025 | United States |
| Western Reserve Vision Care | Beachwood | Ohio | 44122 | United States |
| Primary Eyecare Group, P.C. | Brentwood | Tennessee | 37027 | United States |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | Lens Stability | Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation. | Subjects/eyes that completed the study were analyzed. A total of 168 eyes/84 subjects were analyzed. | Posted | Number | Eyes | 10-15 minutes after insertion |
|
|
|
|
| Primary | Subjective Lens Comfort | A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. >0=comfortable, <0=uncomfortable. | Subjects that completed the study were analyzed. | Posted | Least Squares Mean | Standard Error | Units on a scale | 1 and 2 weeks |
|
|
|
|
| Primary | Subjective Vision | A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive vision outcomes. The analysis shows the difference in outcome between the test and control. >0=satisfactory vision, <0=unsatisfactory vision. | Subjects that completed the study were analyzed. | Posted | Least Squares Mean | Standard Error | Units on a scale | 1 and 2 weeks |
|
|
|
|
| Primary | Overall Corneal Staining | Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe. | Subjects that completed the study were analyzed. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 2 weeks use |
|
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Alphafilcon A Toric / Senofilcon A Toric | alphafilcon A toric work bilaterally during first 2-week period, senofilcon A toric work bilaterally during second 2-week period. | 0 | 45 | 0 | 45 |
The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.