Astigmatism
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEstenfilcon A
contact lens
DEVICEetafilcon A
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 42 Years
Healthy volunteers
Yes
Inclusion criteria
A person is eligible for inclusion in the study if he/she: * Is between 18 years of age and 42 years of age. * Soft contact lens wearers who are not required to have Presbyopic correction. * Soft contact lens wearers without trouble. * Soft contact lens wearers who have the correctable astigmatism by lenses used in this study in the both eyes. * Has a prescribed SCL (Soft Contact Lens) power within the range of powers of the SCL for astigmatism which is used in this study. * Can achieve a corrected visual acuity of 1.0 or better. * Can read and understand the study information document, and sign the participation consent form. * Can visit the clinic at designated examination visits. * Has received periodical examinations at an eye clinic within the past two years.
Exclusion criteria
A person will be excluded from the study if he/she: * Has a systemic disease that may affect the ocular health. * Is pregnant or lactating. * Has received a systemic or local medication that may affect this study. * Has an infectious eye disease. * Has eye and systemic active allergic diseases that interferes with SCL wear. * Has an eye disease which is clinically judged to be severe such as corneal vascularization, limbal hyperemia, and corneal epithelium disorder * Has a history of hard contact lens wear within 30 days. * Is currently participating in another clinical research study. * Has undergone refractive surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort | 2 weeks | 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 |
| Dryness | 2 weeks | 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 |
| Clarity of Vision | 2 weeks | 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 |
| Stability of Vision | 2 weeks | 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 |
| Lens Handling | 2 weeks | 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 |
| Overall Satisfaction | 2 weeks | Overall satisfaction for stenfilcon A and etafilcon A toric lens pair is assessed. scale 0-10, 0=extremely un-satisfy, 10=very satisfy |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Total participants enrolled | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 29 years STANDARD_DEVIATION 8 |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 41 |
| other Total, other adverse events | 0 / 41 | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 | 0 / 41 |
Outcome results
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
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A | Clarity of Vision | 8.5 units on a scale | Standard Deviation 1.9 |
| Etafilcon A Toric | Clarity of Vision | 7.8 units on a scale | Standard Deviation 2.4 |
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
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A | Comfort | 8.2 units on a scale | Standard Deviation 2 |
| Etafilcon A Toric | Comfort | 7.4 units on a scale | Standard Deviation 2.4 |
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
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A | Dryness | 8.0 units on a scale | Standard Deviation 2 |
| Etafilcon A Toric | Dryness | 7.4 units on a scale | Standard Deviation 2.2 |
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
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A | Lens Handling | At Insertion | 8.8 units on a scale | Standard Deviation 1.8 |
| Stenfilcon A | Lens Handling | At Removal | 7.2 units on a scale | Standard Deviation 2.9 |
| Etafilcon A Toric | Lens Handling | At Insertion | 7.6 units on a scale | Standard Deviation 2.5 |
| Etafilcon A Toric | Lens Handling | At Removal | 8.9 units on a scale | Standard Deviation 1.9 |
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
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A | Overall Satisfaction | 8.1 units on a scale | Standard Deviation 2 |
| Etafilcon A Toric | Overall Satisfaction | 7.2 units on a scale | Standard Deviation 2.5 |
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
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A | Stability of Vision | 8.6 units on a scale | Standard Deviation 1.8 |
| Etafilcon A Toric | Stability of Vision | 8.0 units on a scale | Standard Deviation 2.2 |