Myopia
Conditions
Brief summary
The objective of this study is to compare the clinical performance of senofilcon A lens with the stenfilcon A lens each for one week of daily disposable wear.
Detailed description
The purpose of this bilateral cross-over study is to evaluate the clinical performance of senofilcon A lens with the stenfilcon A lens. In particular, the study will focus on ocular physiology, lens fit, lens surface, visual acuity, and subjective response.
Interventions
DEVICESenofilcon A
contact lens
DEVICEStenfilcon A
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects will only be eligible for the study if: * They are of legal age (18) and capacity to volunteer. * They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. * They are willing and able to follow the protocol. * They agree not to participate in other clinical research for the duration of this study. * They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive) * They have a spectacle cylindrical correction of -0.75D or less in each eye. * At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range. * They currently use soft contact lenses or have done so in the previous six months. * They are willing to comply with the wear schedule (at least six days per week and for at least eight hours per day).
Exclusion criteria
Subjects will not be eligible to take part in the study if: * They have an ocular disorder which would normally contra-indicate contact lens wear. * They have a systemic disorder which would normally contra-indicate contact lens wear. * They are using any topical medication such as eye drops or ointment. * They have had cataract surgery. * They have had corneal refractive surgery. * They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. * They are pregnant or lactating. * They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. * They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction. * They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study. * They currently wear either MyDay (daily) or the Acuvue Oasys (2 weekly) lens.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Physiology | Baseline and 1 week | Ocular physiology assessment of senofilcon A and stenfilcon A lenses by biomicroscopy for the following: corneal staining, conjunctival hyperaemia, limbal hyperaemia, and conjunctival staining. Scale 0-4, 0.25 steps, 0=normal, 4=severe. |
| Overall Subjective Score of Lenses | Baseline and 1 week | Subjective responses will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, 100=excellent. |
| Comfort | Baseline and 1 week | Subjective responses for comfort will be evaluated for each pair using questionnaire. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt. |
| Dryness | 1 week | Subjective responses for dryness will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness. |
| Vision | Baseline and 1 week | Subjective responses for vision will be evaluated for each pair using questionnaire. Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Surface - Debris | Baseline | Lens debris for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe |
| Horizontal Centration | Baseline | Lens fit, horizontal centration will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal |
| Lens Surface - Wettability | Baseline | Lens wettability for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe |
| Vertical Centration | Baseline | Lens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal |
| Lens Movement | Baseline | Lens movement assessed for stenfilcon A and senofilcon A at baseline using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive. |
| Visual Acuity | Baseline and 1 week | Measurement of visual acuity (VA) for senofilcon A and stenfilcon A assessed at baseline and 1 week using logMAR VA chart. |
| Lens Surface - Deposition | Baseline | Lens surface for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Baseline Characteristics Participants were randomized to wear senofilcon A or stenfilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
Stenfilcon A: contact lens | 70 |
| Total | 70 |
Baseline characteristics
| Characteristic | Overall Baseline Characteristics |
|---|---|
| Age, Continuous | 30.6 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 70 | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 | 0 / 70 |
Outcome results
Primary
Comfort
Subjective responses for comfort will be evaluated for each pair using questionnaire. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
Time frame: Baseline and 1 week
Population: A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Senofilcon A | Comfort | Baseline | 90.8 units on a scale | Standard Deviation 10.2 |
| Senofilcon A | Comfort | 1 week | 87.0 units on a scale | Standard Deviation 11.5 |
| Stenfilcon A | Comfort | Baseline | 90.5 units on a scale | Standard Deviation 10.7 |
| Stenfilcon A | Comfort | 1 week | 82.1 units on a scale | Standard Deviation 14 |
Primary
Dryness
Subjective responses for dryness will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness.
Time frame: 1 week
Population: A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Dryness | 82.3 units on a scale | Standard Deviation 14.3 |
| Stenfilcon A | Dryness | 77.7 units on a scale | Standard Deviation 17.8 |
Primary
Ocular Physiology
Ocular physiology assessment of senofilcon A and stenfilcon A lenses by biomicroscopy for the following: corneal staining, conjunctival hyperaemia, limbal hyperaemia, and conjunctival staining. Scale 0-4, 0.25 steps, 0=normal, 4=severe.
Time frame: Baseline and 1 week
Population: Protocol deviations occurred for 2 participants and therefore resulted in incomplete data sets.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Senofilcon A | Ocular Physiology | Baseline - Corneal staining | 0.13 units on a scale | Standard Deviation 0.3 |
| Senofilcon A | Ocular Physiology | 1 week - Corneal staining | 0.21 units on a scale | Standard Deviation 0.34 |
| Senofilcon A | Ocular Physiology | Baseline - Conjunctival staining | 0.21 units on a scale | Standard Deviation 0.3 |
| Senofilcon A | Ocular Physiology | 1 week - Conjunctival staining | 0.82 units on a scale | Standard Deviation 0.51 |
| Senofilcon A | Ocular Physiology | Baseline - Conjunctival hyperaemia | 0.81 units on a scale | Standard Deviation 0.23 |
| Senofilcon A | Ocular Physiology | 1 week - Conjunctival hyperaemia | 0.82 units on a scale | Standard Deviation 0.25 |
| Senofilcon A | Ocular Physiology | Baseline - Limbal hyperaemia | 0.70 units on a scale | Standard Deviation 0.28 |
| Senofilcon A | Ocular Physiology | 1 week - Limbal hyperaemia | 0.69 units on a scale | Standard Deviation 0.26 |
| Stenfilcon A | Ocular Physiology | 1 week - Limbal hyperaemia | 0.75 units on a scale | Standard Deviation 0.26 |
| Stenfilcon A | Ocular Physiology | Baseline - Corneal staining | 0.13 units on a scale | Standard Deviation 0.3 |
| Stenfilcon A | Ocular Physiology | Baseline - Conjunctival hyperaemia | 0.81 units on a scale | Standard Deviation 0.23 |
| Stenfilcon A | Ocular Physiology | 1 week - Corneal staining | 0.15 units on a scale | Standard Deviation 0.29 |
| Stenfilcon A | Ocular Physiology | Baseline - Limbal hyperaemia | 0.70 units on a scale | Standard Deviation 0.28 |
| Stenfilcon A | Ocular Physiology | Baseline - Conjunctival staining | 0.21 units on a scale | Standard Deviation 0.3 |
| Stenfilcon A | Ocular Physiology | 1 week - Conjunctival hyperaemia | 0.86 units on a scale | Standard Deviation 0.24 |
| Stenfilcon A | Ocular Physiology | 1 week - Conjunctival staining | 0.48 units on a scale | Standard Deviation 0.43 |
Primary
Overall Subjective Score of Lenses
Subjective responses will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, 100=excellent.
Time frame: Baseline and 1 week
Population: A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Senofilcon A | Overall Subjective Score of Lenses | Baseline | 92.3 units on a scale | Standard Deviation 8.8 |
| Senofilcon A | Overall Subjective Score of Lenses | 1 week | 87.0 units on a scale | Standard Deviation 13.1 |
| Stenfilcon A | Overall Subjective Score of Lenses | Baseline | 89.4 units on a scale | Standard Deviation 11.1 |
| Stenfilcon A | Overall Subjective Score of Lenses | 1 week | 80.0 units on a scale | Standard Deviation 18.3 |
Primary
Vision
Subjective responses for vision will be evaluated for each pair using questionnaire. Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent.
Time frame: Baseline and 1 week
Population: A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Senofilcon A | Vision | Baseline | 94.7 units on a scale | Standard Deviation 6.8 |
| Senofilcon A | Vision | 1 week | 93.4 units on a scale | Standard Deviation 7.9 |
| Stenfilcon A | Vision | Baseline | 91.9 units on a scale | Standard Deviation 9.5 |
| Stenfilcon A | Vision | 1 week | 88.4 units on a scale | Standard Deviation 12.4 |
Secondary
Horizontal Centration
Lens fit, horizontal centration will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A | Horizontal Centration | Extremely nasal | 0 percentage of subjects |
| Senofilcon A | Horizontal Centration | Slightly temporal | 36 percentage of subjects |
| Senofilcon A | Horizontal Centration | Optimum | 61 percentage of subjects |
| Senofilcon A | Horizontal Centration | Extremely temporal | 0 percentage of subjects |
| Senofilcon A | Horizontal Centration | Slightly nasal | 3 percentage of subjects |
| Stenfilcon A | Horizontal Centration | Extremely temporal | 0 percentage of subjects |
| Stenfilcon A | Horizontal Centration | Extremely nasal | 0 percentage of subjects |
| Stenfilcon A | Horizontal Centration | Slightly nasal | 6 percentage of subjects |
| Stenfilcon A | Horizontal Centration | Optimum | 73 percentage of subjects |
| Stenfilcon A | Horizontal Centration | Slightly temporal | 21 percentage of subjects |
Secondary
Horizontal Centration
Lens fit, horizontal centration, will be assessed for senofilcon A and stenfilcon A at 1 week for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal
Time frame: 1 Week
Population: A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A | Horizontal Centration | Slightly nasal | 1.4 percentage of subjects |
| Senofilcon A | Horizontal Centration | Slightly temporal | 26.1 percentage of subjects |
| Senofilcon A | Horizontal Centration | Optimum | 72.5 percentage of subjects |
| Senofilcon A | Horizontal Centration | Extremely temporal | 0.0 percentage of subjects |
| Senofilcon A | Horizontal Centration | Extremely nasal | 0.0 percentage of subjects |
| Stenfilcon A | Horizontal Centration | Extremely temporal | 0.0 percentage of subjects |
| Stenfilcon A | Horizontal Centration | Extremely nasal | 0.0 percentage of subjects |
| Stenfilcon A | Horizontal Centration | Slightly nasal | 7.0 percentage of subjects |
| Stenfilcon A | Horizontal Centration | Optimum | 70.0 percentage of subjects |
| Stenfilcon A | Horizontal Centration | Slightly temporal | 23.0 percentage of subjects |
Secondary
Lens Movement
Lens movement assessed for stenfilcon A and senofilcon A at baseline using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A | Lens Movement | Slightly inadequate | 29 percentage of subjects |
| Senofilcon A | Lens Movement | Slightly excessive | 4 percentage of subjects |
| Senofilcon A | Lens Movement | Optimum | 67 percentage of subjects |
| Senofilcon A | Lens Movement | Extremely excessive | 0 percentage of subjects |
| Senofilcon A | Lens Movement | Extremely inadequate | 0 percentage of subjects |
| Stenfilcon A | Lens Movement | Extremely excessive | 0 percentage of subjects |
| Stenfilcon A | Lens Movement | Extremely inadequate | 0 percentage of subjects |
| Stenfilcon A | Lens Movement | Slightly inadequate | 3 percentage of subjects |
| Stenfilcon A | Lens Movement | Optimum | 64 percentage of subjects |
| Stenfilcon A | Lens Movement | Slightly excessive | 33 percentage of subjects |
Secondary
Lens Movement
Lens movement assessed for stenfilcon A and senofilcon A at 1 week using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Time frame: 1 Week
Population: A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A | Lens Movement | Slightly inadequate | 42 percentage of subjects |
| Senofilcon A | Lens Movement | Slightly excessive | 1 percentage of subjects |
| Senofilcon A | Lens Movement | Optimum | 57 percentage of subjects |
| Senofilcon A | Lens Movement | Extremely excessive | 0 percentage of subjects |
| Senofilcon A | Lens Movement | Extremely inadequate | 0 percentage of subjects |
| Stenfilcon A | Lens Movement | Extremely excessive | 0 percentage of subjects |
| Stenfilcon A | Lens Movement | Extremely inadequate | 0 percentage of subjects |
| Stenfilcon A | Lens Movement | Slightly inadequate | 7 percentage of subjects |
| Stenfilcon A | Lens Movement | Optimum | 65 percentage of subjects |
| Stenfilcon A | Lens Movement | Slightly excessive | 28 percentage of subjects |
Secondary
Lens Surface - Debris
Lens debris for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: 1 week
Population: A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A | Lens Surface - Debris | Trace | 14.5 percentage of subjects |
| Senofilcon A | Lens Surface - Debris | Moderate | 0.0 percentage of subjects |
| Senofilcon A | Lens Surface - Debris | Mild | 1.4 percentage of subjects |
| Senofilcon A | Lens Surface - Debris | Severe | 0.0 percentage of subjects |
| Senofilcon A | Lens Surface - Debris | Normal | 84.1 percentage of subjects |
| Stenfilcon A | Lens Surface - Debris | Severe | 0.0 percentage of subjects |
| Stenfilcon A | Lens Surface - Debris | Normal | 96.0 percentage of subjects |
| Stenfilcon A | Lens Surface - Debris | Trace | 4.0 percentage of subjects |
| Stenfilcon A | Lens Surface - Debris | Mild | 0.0 percentage of subjects |
| Stenfilcon A | Lens Surface - Debris | Moderate | 0.0 percentage of subjects |
Secondary
Lens Surface - Debris
Lens debris for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A | Lens Surface - Debris | Trace | 14.3 percentage of subjects |
| Senofilcon A | Lens Surface - Debris | Moderate | 1.4 percentage of subjects |
| Senofilcon A | Lens Surface - Debris | Mild | 1.4 percentage of subjects |
| Senofilcon A | Lens Surface - Debris | Severe | 0.0 percentage of subjects |
| Senofilcon A | Lens Surface - Debris | Normal | 82.9 percentage of subjects |
| Stenfilcon A | Lens Surface - Debris | Severe | 0.0 percentage of subjects |
| Stenfilcon A | Lens Surface - Debris | Normal | 93.0 percentage of subjects |
| Stenfilcon A | Lens Surface - Debris | Trace | 7.0 percentage of subjects |
| Stenfilcon A | Lens Surface - Debris | Mild | 0.0 percentage of subjects |
| Stenfilcon A | Lens Surface - Debris | Moderate | 0.0 percentage of subjects |
Secondary
Lens Surface - Deposition
Lens surface for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: 1 week
Population: A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A | Lens Surface - Deposition | Trace | 7.2 percentage of subjects |
| Senofilcon A | Lens Surface - Deposition | Moderate | 0.0 percentage of subjects |
| Senofilcon A | Lens Surface - Deposition | Mild | 1.4 percentage of subjects |
| Senofilcon A | Lens Surface - Deposition | Severe | 0.0 percentage of subjects |
| Senofilcon A | Lens Surface - Deposition | Normal | 91.3 percentage of subjects |
| Stenfilcon A | Lens Surface - Deposition | Severe | 0.0 percentage of subjects |
| Stenfilcon A | Lens Surface - Deposition | Normal | 99.0 percentage of subjects |
| Stenfilcon A | Lens Surface - Deposition | Trace | 1.0 percentage of subjects |
| Stenfilcon A | Lens Surface - Deposition | Mild | 0.0 percentage of subjects |
| Stenfilcon A | Lens Surface - Deposition | Moderate | 0.0 percentage of subjects |
Secondary
Lens Surface - Deposition
Lens surface for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A | Lens Surface - Deposition | Trace | 6 percentage of subjects |
| Senofilcon A | Lens Surface - Deposition | Moderate | 0 percentage of subjects |
| Senofilcon A | Lens Surface - Deposition | Mild | 0 percentage of subjects |
| Senofilcon A | Lens Surface - Deposition | Severe | 0 percentage of subjects |
| Senofilcon A | Lens Surface - Deposition | Normal | 94 percentage of subjects |
| Stenfilcon A | Lens Surface - Deposition | Severe | 0 percentage of subjects |
| Stenfilcon A | Lens Surface - Deposition | Normal | 97 percentage of subjects |
| Stenfilcon A | Lens Surface - Deposition | Trace | 3 percentage of subjects |
| Stenfilcon A | Lens Surface - Deposition | Mild | 0 percentage of subjects |
| Stenfilcon A | Lens Surface - Deposition | Moderate | 0 percentage of subjects |
Secondary
Lens Surface - Wettability
Lens wettability for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: 1 week
Population: A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A | Lens Surface - Wettability | Normal | 81.2 percentage of subjects |
| Senofilcon A | Lens Surface - Wettability | Moderate | 1.4 percentage of subjects |
| Senofilcon A | Lens Surface - Wettability | Trace | 15.9 percentage of subjects |
| Senofilcon A | Lens Surface - Wettability | Severe | 0.0 percentage of subjects |
| Senofilcon A | Lens Surface - Wettability | Mild | 1.4 percentage of subjects |
| Stenfilcon A | Lens Surface - Wettability | Severe | 0.0 percentage of subjects |
| Stenfilcon A | Lens Surface - Wettability | Mild | 4.0 percentage of subjects |
| Stenfilcon A | Lens Surface - Wettability | Normal | 71.0 percentage of subjects |
| Stenfilcon A | Lens Surface - Wettability | Trace | 25.0 percentage of subjects |
| Stenfilcon A | Lens Surface - Wettability | Moderate | 0.0 percentage of subjects |
Secondary
Lens Surface - Wettability
Lens wettability for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A | Lens Surface - Wettability | Trace | 20 percentage of subjects |
| Senofilcon A | Lens Surface - Wettability | Moderate | 0 percentage of subjects |
| Senofilcon A | Lens Surface - Wettability | Mild | 1 percentage of subjects |
| Senofilcon A | Lens Surface - Wettability | Severe | 0 percentage of subjects |
| Senofilcon A | Lens Surface - Wettability | Normal | 79 percentage of subjects |
| Stenfilcon A | Lens Surface - Wettability | Severe | 0 percentage of subjects |
| Stenfilcon A | Lens Surface - Wettability | Normal | 86 percentage of subjects |
| Stenfilcon A | Lens Surface - Wettability | Trace | 11 percentage of subjects |
| Stenfilcon A | Lens Surface - Wettability | Mild | 3 percentage of subjects |
| Stenfilcon A | Lens Surface - Wettability | Moderate | 0 percentage of subjects |
Secondary
Vertical Centration
Lens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at 1 week for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal
Time frame: 1 Week
Population: A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A | Vertical Centration | Slightly nasal | 20.3 percentage of subjects |
| Senofilcon A | Vertical Centration | Slightly temporal | 14.5 percentage of subjects |
| Senofilcon A | Vertical Centration | Optimum | 65.2 percentage of subjects |
| Senofilcon A | Vertical Centration | Extremely temporal | 0.0 percentage of subjects |
| Senofilcon A | Vertical Centration | Extremely nasal | 0.0 percentage of subjects |
| Stenfilcon A | Vertical Centration | Extremely temporal | 0.0 percentage of subjects |
| Stenfilcon A | Vertical Centration | Extremely nasal | 0.0 percentage of subjects |
| Stenfilcon A | Vertical Centration | Slightly nasal | 23.0 percentage of subjects |
| Stenfilcon A | Vertical Centration | Optimum | 65.0 percentage of subjects |
| Stenfilcon A | Vertical Centration | Slightly temporal | 12.0 percentage of subjects |
Secondary
Vertical Centration
Lens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A | Vertical Centration | Slightly nasal | 17.0 percentage of subjects |
| Senofilcon A | Vertical Centration | Optimum | 64.0 percentage of subjects |
| Senofilcon A | Vertical Centration | Slightly temporal | 19.0 percentage of subjects |
| Senofilcon A | Vertical Centration | Extremely temporal | 0.0 percentage of subjects |
| Senofilcon A | Vertical Centration | Extremely nasal | 0.0 percentage of subjects |
| Stenfilcon A | Vertical Centration | Extremely nasal | 0.0 percentage of subjects |
| Stenfilcon A | Vertical Centration | Extremely temporal | 0.0 percentage of subjects |
| Stenfilcon A | Vertical Centration | Optimum | 65.7 percentage of subjects |
| Stenfilcon A | Vertical Centration | Slightly nasal | 15.7 percentage of subjects |
| Stenfilcon A | Vertical Centration | Slightly temporal | 18.6 percentage of subjects |
Secondary
Visual Acuity
Measurement of visual acuity (VA) for senofilcon A and stenfilcon A assessed at baseline and 1 week using logMAR VA chart.
Time frame: Baseline and 1 week
Population: Protocol deviations occurred and therefore resulted in incomplete data sets.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Senofilcon A | Visual Acuity | 1 week: High Contrast | -0.13 LogMAR | Standard Deviation 0.07 |
| Senofilcon A | Visual Acuity | Baseline: Low Contrast | 0.12 LogMAR | Standard Deviation 0.1 |
| Senofilcon A | Visual Acuity | 1 week: Low Contrast | 0.13 LogMAR | Standard Deviation 0.09 |
| Senofilcon A | Visual Acuity | Baseline: High Contrast | -0.14 LogMAR | Standard Deviation 0.07 |
| Stenfilcon A | Visual Acuity | 1 week: Low Contrast | 0.17 LogMAR | Standard Deviation 0.09 |
| Stenfilcon A | Visual Acuity | Baseline: Low Contrast | 0.16 LogMAR | Standard Deviation 0.1 |
| Stenfilcon A | Visual Acuity | 1 week: High Contrast | -0.10 LogMAR | Standard Deviation 0.09 |
| Stenfilcon A | Visual Acuity | Baseline: High Contrast | -0.11 LogMAR | Standard Deviation 0.08 |