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The aim of this study is to evaluate the clinical performance of stenfilcon A toric lenses compared with etafilcon A toric lenses for astigmatism. If it is valuable, the clinical performance of stenfilcon A toric lens is also evaluated compared with habitual lenses.
This is a multi-sites, 50 subjects, randomized, open labeled, bilateral wear, dispensing study. Participants will be randomized to wear first lens pair for two weeks, and then crossover to second lens pair for two weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stenfilcon A | Experimental | Participants will be randomized to wear stenfilcon A lens pair for two weeks during the cross over study. |
|
| etafilcon A | Active Comparator | Participants will be randomized to wear etafilcon A lens pair for two weeks during the cross over study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stenfilcon A | Device | contact lens |
| |
| etafilcon A |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Wearing comfort (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0= extremely uncomfortable cannot wear at all, 10=very comfortable and feel no lens at all | 2 weeks |
| Dryness | Dryness (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=extremely dried and cannot wear lens, 10=feel no dryness at all | 2 weeks |
| Clarity of Vision | Clarity of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=blur vision and cannot see at all, 10=very clear with no blur vision at all | 2 weeks |
| Stability of Vision | Stability of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=unstable vision and cannot see at all, 10=always stable vision | 2 weeks |
| Lens Handling | Lens handling for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=cannot handle at all, 10=no problem at all | 2 weeks |
| Overall Satisfaction | Overall satisfaction for stenfilcon A and etafilcon A toric lens pair is assessed. scale 0-10, 0=extremely un-satisfy, 10=very satisfy | 2 weeks |
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Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
Exclusion Criteria:
A person will be excluded from the study if he/she:
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| Name | Affiliation | Role |
|---|---|---|
| Yuji Kodama, MD, PhD | Director, Kodama Eye Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kodama Eye Clinic | Terada | Kyoto | 610-0121 | Japan | ||
| Dougenzaka Ioti Eye Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stenfilcon A First, Then Etafilcon A | Participants randomized to wear stenfilcon A toric lens pair for two weeks then etafilcon A toric lens pair in the cross over study. |
| FG001 | Etafilcon A First, Then Stenfilcon A | Participants randomized to wear stenfilcon A toric lens pair for two weeks then etafilcon A toric lens pair in the cross over study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lens 1 |
| |||||||||||||
| Lens 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Total participants enrolled |
| 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 | Comfort | Wearing comfort (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0= extremely uncomfortable cannot wear at all, 10=very comfortable and feel no lens at all | Posted | Mean | Standard Deviation | units on a scale | 2 weeks | eyes | eyes |
|
2 weeks for each round of lens wear.
Adverse events were assessed for during the follow-up study visits.
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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 | Stenfilcon A | Participants randomized to wear stenfilcon A lens pair either as first or second pair in this crossover study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose Vega, O.D., MSc., FAAO | CooperVision | 9256213761 | javega@coopervision.com |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Device |
contact lens |
|
| Shibuya City |
| Tokyo-to |
| 150-0043 |
| Japan |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Dryness | Dryness (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=extremely dried and cannot wear lens, 10=feel no dryness at all | Posted | Mean | Standard Deviation | units on a scale | 2 weeks | eyes | eyes |
|
|
|
| Primary | Clarity of Vision | Clarity of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=blur vision and cannot see at all, 10=very clear with no blur vision at all | Posted | Mean | Standard Deviation | units on a scale | 2 weeks | eyes | eyes |
|
|
|
| Primary | Stability of Vision | Stability of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=unstable vision and cannot see at all, 10=always stable vision | Posted | Mean | Standard Deviation | units on a scale | 2 weeks | eyes | eyes |
|
|
|
| Primary | Lens Handling | Lens handling for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=cannot handle at all, 10=no problem at all | Posted | Mean | Standard Deviation | units on a scale | 2 weeks | eyes | eyes |
|
|
|
| Primary | Overall Satisfaction | Overall satisfaction for stenfilcon A and etafilcon A toric lens pair is assessed. scale 0-10, 0=extremely un-satisfy, 10=very satisfy | Posted | Mean | Standard Deviation | units on a scale | 2 weeks | eyes | eyes |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Etafilcon A | Participants randomized to wear etafilcon A lens pair either as first or second pair in this crossover study. | 0 | 41 | 0 | 41 | 0 | 41 |
Disclosure restriction on the PI is that the sponsor should be notified of any results communications and has ability to review.