Myopia
Conditions
Brief summary
This study aims to compare the clinical performance and subjective acceptance of the narafilcon A lens with the stenfilcon A lens when used on a daily wear, daily disposable basis.
Detailed description
This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross comparison. Seventy subjects will use each lens type for a week in a random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.
Interventions
DEVICEnarafilcon 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: 1. They are of legal age (18) and capacity to volunteer. 2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. 3. They are willing and able to follow the protocol. 4. They agree not to participate in other clinical research for the duration of this study. 5. They have a contact lens spherical prescription between -1.00 to - 6.00D (Diopters) (inclusive) 6. They have a spectacle cylindrical correction of -0.75D or less in each eye. 7. They can be satisfactorily fitted with the study lens types. 8. 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. 9. They currently use soft contact lenses or have done so in the previous six months. 10. They are willing to comply with the wear schedule (at least six days per week and for at least eight hours per day). 11. They own a wearable pair of spectacles.
Exclusion criteria
* Subjects will not be eligible to take part in the study if: 1. They have an ocular disorder which would normally contra-indicate contact lens wear. 2. They have a systemic disorder which would normally contra-indicate contact lens wear. 3. They are using any topical medication such as eye drops or ointment. 4. They have had cataract surgery. 5. They have had corneal refractive surgery. 6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 7. They are pregnant or breast-feeding. 8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. 9. 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. 10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study. 11. They currently wear either the stenfilcon A lens or narafilcon A lens.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Physiology | 1 week | Ocular physiology assessment of narafilcon A and stenfilcon A lenses by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). |
| Visual Acuity | 1 week | Visual acuity for narafilcon A and stenfilcon A are assessed by LogMAR. High contrast is measured with black letters on a white background. Low contrast is measured with gray letters on a white background. |
| Comfort Level of Stenfilcon A and Narafilcon A Lenses | 1 week | Subjective responses for overall comfort will be evaluated for each pair using questionnaire (Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). |
| Dryness of Stenfilcon A and Narafilcon A Lenses | 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 of Stenfilcon A and Narafilcon A Lenses | 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). |
| Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses | 1 week | Lens surface for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe) |
| Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses | 1 week | Lens wettability for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe) |
| Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses | 1 week | Horizontal centration assessed for narafilcon A and stenfilcon A lenses categorized as extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal. |
| Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses | 1 week | Vertical centration assessed for narafilcon A and stenfilcon A lenses and graded as extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal. |
| Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses | 1 week | Corneal coverage will be assessed for narafilcon A and stenfilcon A and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive. |
| Lens Movement | 1 week | Lens movement assessed for narafilcon A and senofilcon A lenses and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive. |
Countries
United Kingdom
Participant flow
Pre-assignment details
There were 72 participants were enrolled in the study, of which 70 were dispensed a contact lens to wear and 2 failed screening.
Participants by arm
| Arm | Count |
|---|---|
| Overall Number of Baseline Participants Total number of participants enrolled in the study. | 72 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Adverse Event | 0 | 1 |
| First Intervention | Protocol Violation | 0 | 1 |
| Second Intervention | Poor Lens Fit | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Number of Baseline Participants |
|---|---|
| Age, Continuous | 32.8 years STANDARD_DEVIATION 11.4 |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 70 |
| other Total, other adverse events | 2 / 70 | 6 / 70 |
| serious Total, serious adverse events | 0 / 70 | 0 / 70 |
Outcome results
Primary
Comfort Level of Stenfilcon A and Narafilcon A Lenses
Subjective responses for overall 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: 1 week
Population: There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A | Comfort Level of Stenfilcon A and Narafilcon A Lenses | 91.4 units on a scale | Standard Deviation 9.8 |
| Narafilcon A | Comfort Level of Stenfilcon A and Narafilcon A Lenses | 83.1 units on a scale | Standard Deviation 14.8 |
Primary
Dryness of Stenfilcon A and Narafilcon A Lenses
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: There were 2 participants excluded from the analysis for narafilcon A due to protocol deviations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A | Dryness of Stenfilcon A and Narafilcon A Lenses | 82.1 units on a scale | Standard Deviation 17.2 |
| Narafilcon A | Dryness of Stenfilcon A and Narafilcon A Lenses | 81.2 units on a scale | Standard Deviation 16.7 |
Primary
Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses
Corneal coverage will be assessed for narafilcon A and stenfilcon A and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Time frame: 1 week
Population: There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stenfilcon A | Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses | Extremely excessive | 0 Participants |
| Stenfilcon A | Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses | Extremely inadequate | 0 Participants |
| Stenfilcon A | Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses | Slightly inadequate | 4 Participants |
| Stenfilcon A | Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses | Optimum | 56 Participants |
| Stenfilcon A | Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses | Slighlty excessive | 8 Participants |
| Narafilcon A | Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses | Slighlty excessive | 6 Participants |
| Narafilcon A | Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses | Optimum | 60 Participants |
| Narafilcon A | Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses | Extremely inadequate | 0 Participants |
| Narafilcon A | Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses | Extremely excessive | 0 Participants |
| Narafilcon A | Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses | Slightly inadequate | 2 Participants |
Primary
Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses
Horizontal centration assessed for narafilcon A and stenfilcon A lenses categorized as extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
Time frame: 1 week
Population: There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stenfilcon A | Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses | Slightly Nasal | 0 Participants |
| Stenfilcon A | Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses | Slightly Temporal | 24 Participants |
| Stenfilcon A | Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses | Optimum | 44 Participants |
| Stenfilcon A | Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses | Extremely Temporal | 0 Participants |
| Stenfilcon A | Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses | Extremely Nasal | 0 Participants |
| Narafilcon A | Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses | Extremely Temporal | 0 Participants |
| Narafilcon A | Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses | Extremely Nasal | 0 Participants |
| Narafilcon A | Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses | Slightly Nasal | 0 Participants |
| Narafilcon A | Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses | Optimum | 46 Participants |
| Narafilcon A | Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses | Slightly Temporal | 22 Participants |
Primary
Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses
Vertical centration assessed for narafilcon A and stenfilcon A lenses and graded as extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.
Time frame: 1 week
Population: There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stenfilcon A | Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses | Slightly inferior | 11 Participants |
| Stenfilcon A | Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses | Slightly superior | 15 Participants |
| Stenfilcon A | Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses | Optimum | 42 Participants |
| Stenfilcon A | Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses | Extremely superior | 0 Participants |
| Stenfilcon A | Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses | Extremely inferior | 0 Participants |
| Narafilcon A | Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses | Extremely superior | 0 Participants |
| Narafilcon A | Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses | Extremely inferior | 0 Participants |
| Narafilcon A | Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses | Slightly inferior | 12 Participants |
| Narafilcon A | Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses | Optimum | 48 Participants |
| Narafilcon A | Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses | Slightly superior | 8 Participants |
Primary
Lens Movement
Lens movement assessed for narafilcon A and senofilcon A lenses and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Time frame: 1 week
Population: There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stenfilcon A | Lens Movement | Slightly inadequate | 3 Participants |
| Stenfilcon A | Lens Movement | Slightly excessive | 10 Participants |
| Stenfilcon A | Lens Movement | Optimum | 55 Participants |
| Stenfilcon A | Lens Movement | Extremely excessive | 0 Participants |
| Stenfilcon A | Lens Movement | Extremely inadequate | 0 Participants |
| Narafilcon A | Lens Movement | Extremely excessive | 0 Participants |
| Narafilcon A | Lens Movement | Extremely inadequate | 0 Participants |
| Narafilcon A | Lens Movement | Slightly inadequate | 5 Participants |
| Narafilcon A | Lens Movement | Optimum | 54 Participants |
| Narafilcon A | Lens Movement | Slightly excessive | 9 Participants |
Primary
Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses
Lens surface for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)
Time frame: 1 week
Population: There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stenfilcon A | Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses | Grade 1 | 4 Participants |
| Stenfilcon A | Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses | Grade 3 | 0 Participants |
| Stenfilcon A | Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses | Grade 2 | 0 Participants |
| Stenfilcon A | Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses | Grade 4 | 0 Participants |
| Stenfilcon A | Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses | Grade 0 | 64 Participants |
| Narafilcon A | Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses | Grade 4 | 0 Participants |
| Narafilcon A | Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses | Grade 0 | 62 Participants |
| Narafilcon A | Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses | Grade 1 | 5 Participants |
| Narafilcon A | Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses | Grade 2 | 1 Participants |
| Narafilcon A | Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses | Grade 3 | 0 Participants |
Primary
Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses
Lens wettability for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)
Time frame: 1 week
Population: There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stenfilcon A | Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses | Grade 1 | 8 Participants |
| Stenfilcon A | Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses | Grade 3 | 1 Participants |
| Stenfilcon A | Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses | Grade 2 | 4 Participants |
| Stenfilcon A | Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses | Grade 4 | 0 Participants |
| Stenfilcon A | Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses | Grade 0 | 55 Participants |
| Narafilcon A | Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses | Grade 4 | 0 Participants |
| Narafilcon A | Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses | Grade 0 | 59 Participants |
| Narafilcon A | Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses | Grade 1 | 5 Participants |
| Narafilcon A | Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses | Grade 2 | 4 Participants |
| Narafilcon A | Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses | Grade 3 | 0 Participants |
Primary
Ocular Physiology
Ocular physiology assessment of narafilcon A and stenfilcon A lenses by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time frame: 1 week
Population: There were 2 participants excluded from the analysis for narafilcon A due to protocol deviations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A | Ocular Physiology | Conjuctival hyperaemia | 0.84 units on a scale | Standard Deviation 0.25 |
| Stenfilcon A | Ocular Physiology | Limbal hyperaemia | 0.75 units on a scale | Standard Deviation 0.28 |
| Stenfilcon A | Ocular Physiology | Corneal vascularisation | 0.05 units on a scale | Standard Deviation 0.14 |
| Stenfilcon A | Ocular Physiology | Microcysts | 0.00 units on a scale | Standard Deviation 0 |
| Stenfilcon A | Ocular Physiology | Oedema | 0.00 units on a scale | Standard Deviation 0 |
| Stenfilcon A | Ocular Physiology | Corneal staining | 0.31 units on a scale | Standard Deviation 0.41 |
| Stenfilcon A | Ocular Physiology | Conjuctival staining | 0.57 units on a scale | Standard Deviation 0.49 |
| Stenfilcon A | Ocular Physiology | Papillary conjuctivitis | 1.01 units on a scale | Standard Deviation 0.35 |
| Narafilcon A | Ocular Physiology | Papillary conjuctivitis | 1.00 units on a scale | Standard Deviation 0.31 |
| Narafilcon A | Ocular Physiology | Conjuctival hyperaemia | 0.76 units on a scale | Standard Deviation 0.27 |
| Narafilcon A | Ocular Physiology | Oedema | 0.00 units on a scale | Standard Deviation 0 |
| Narafilcon A | Ocular Physiology | Limbal hyperaemia | 0.62 units on a scale | Standard Deviation 0.31 |
| Narafilcon A | Ocular Physiology | Conjuctival staining | 0.76 units on a scale | Standard Deviation 0.64 |
| Narafilcon A | Ocular Physiology | Corneal vascularisation | 0.03 units on a scale | Standard Deviation 0.09 |
| Narafilcon A | Ocular Physiology | Corneal staining | 0.33 units on a scale | Standard Deviation 0.4 |
| Narafilcon A | Ocular Physiology | Microcysts | 0.00 units on a scale | Standard Deviation 0 |
Primary
Vision of Stenfilcon A and Narafilcon A Lenses
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: 1 week
Population: There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A | Vision of Stenfilcon A and Narafilcon A Lenses | 91.4 units on a scale | Standard Deviation 9.4 |
| Narafilcon A | Vision of Stenfilcon A and Narafilcon A Lenses | 88.4 units on a scale | Standard Deviation 14.6 |
Primary
Visual Acuity
Visual acuity for narafilcon A and stenfilcon A are assessed by LogMAR. High contrast is measured with black letters on a white background. Low contrast is measured with gray letters on a white background.
Time frame: 1 week
Population: There were 2 participants excluded from the analysis for narafilcon A at follow up due to protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A | Visual Acuity | High Contrast | -0.12 LogMAR | Standard Deviation 0.07 |
| Stenfilcon A | Visual Acuity | Low Contrast | 0.17 LogMAR | Standard Deviation 0.09 |
| Narafilcon A | Visual Acuity | High Contrast | -0.10 LogMAR | Standard Deviation 0.08 |
| Narafilcon A | Visual Acuity | Low Contrast | 0.17 LogMAR | Standard Deviation 0.1 |