Myopia
Conditions
Brief summary
This study aims to compare the clinical performance of the somfilcon A, nelfilcon A II 2 and omafilcon A II 2 daily disposable contact lenses.
Detailed description
This will be a randomised, subject-masked, crossover, bilateral study, controlled by cross comparison. Fifty subjects will use each lens type for a week in 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
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. 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. 8. They currently use soft contact lenses or have done so in the previous six months. 9. They are willing to comply with the wear schedule (at least five 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: 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Physiology | 1 week | Ocular physiology assessment of by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Fit - Vertical Centration | 1 week | Vertical centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal. |
| Lens Fit - Corneal Coverage | 1 week | Corneal coverage will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal. |
| Lens Fit - Movement | 1 week | Lens movement assessed using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive. |
| Lens Fit - Horizontal Centration | 1 week | Horizontal centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal. |
| Lens Surface - Wettability | 1 week | Lens wettability will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe |
| Visual Acuity | 1 week | Visual acuity will be assessed by LogMAR. |
| Lens Surface - Deposition | 1 week | Lens surface will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe |
Countries
United Kingdom
Participant flow
Recruitment details
55 subjects were recruited for the study, 51 subjects were enrolled and 50 subjects completed the initial follow up visit.
Pre-assignment details
Subjects are randomized to wear each lens brand for one week in a random sequence.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Total participants | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Dispense 1 | Unacceptable Lens Fit | 0 | 0 | 0 | 0 | 1 | 0 |
| Dispense 2 | Unscceptable lens fit | 1 | 0 | 0 | 0 | 1 | 0 |
| Dispense 3 | Unacceptable Lens Fit | 1 | 1 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 35.6 years STANDARD_DEVIATION 12.9 |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 48 | 0 / 49 |
| other Total, other adverse events | 4 / 49 | 3 / 48 | 4 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 48 | 0 / 49 |
Outcome results
Primary
Ocular Physiology
Ocular physiology assessment of by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time frame: 1 week
Population: Protocol deviations and discontinuations account for difference in analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somofilcon A | Ocular Physiology | Paipliiary Conjunctivitis | 0.95 units on a scale | Standard Deviation 0.28 |
| Somofilcon A | Ocular Physiology | Conjunctival Hyperemia | 0.76 units on a scale | Standard Deviation 0.26 |
| Somofilcon A | Ocular Physiology | Microcysts | 0.00 units on a scale | Standard Deviation 0 |
| Somofilcon A | Ocular Physiology | Conjunctival Staining | 1.37 units on a scale | Standard Deviation 0.65 |
| Somofilcon A | Ocular Physiology | Limbal Hyperaemia | 0.63 units on a scale | Standard Deviation 0.24 |
| Somofilcon A | Ocular Physiology | Oedema | 0.00 units on a scale | Standard Deviation 0 |
| Somofilcon A | Ocular Physiology | Corneal Vascularization | 0.05 units on a scale | Standard Deviation 0.11 |
| Somofilcon A | Ocular Physiology | Corneal Staining | 0.33 units on a scale | Standard Deviation 0.42 |
| Nelfilcon A II 2 | Ocular Physiology | Limbal Hyperaemia | 0.66 units on a scale | Standard Deviation 0.3 |
| Nelfilcon A II 2 | Ocular Physiology | Conjunctival Hyperemia | 0.79 units on a scale | Standard Deviation 0.31 |
| Nelfilcon A II 2 | Ocular Physiology | Conjunctival Staining | 0.41 units on a scale | Standard Deviation 0.43 |
| Nelfilcon A II 2 | Ocular Physiology | Paipliiary Conjunctivitis | 0.88 units on a scale | Standard Deviation 0.35 |
| Nelfilcon A II 2 | Ocular Physiology | Corneal Staining | 0.42 units on a scale | Standard Deviation 0.43 |
| Nelfilcon A II 2 | Ocular Physiology | Corneal Vascularization | 0.05 units on a scale | Standard Deviation 0.1 |
| Nelfilcon A II 2 | Ocular Physiology | Microcysts | 0.00 units on a scale | Standard Deviation 0 |
| Nelfilcon A II 2 | Ocular Physiology | Oedema | 0.00 units on a scale | Standard Deviation 0 |
| Omafilcon A ll 2 | Ocular Physiology | Paipliiary Conjunctivitis | 0.93 units on a scale | Standard Deviation 0.34 |
| Omafilcon A ll 2 | Ocular Physiology | Conjunctival Hyperemia | 0.78 units on a scale | Standard Deviation 0.28 |
| Omafilcon A ll 2 | Ocular Physiology | Limbal Hyperaemia | 0.65 units on a scale | Standard Deviation 0.28 |
| Omafilcon A ll 2 | Ocular Physiology | Corneal Vascularization | 0.06 units on a scale | Standard Deviation 0.09 |
| Omafilcon A ll 2 | Ocular Physiology | Microcysts | 0.00 units on a scale | Standard Deviation 0 |
| Omafilcon A ll 2 | Ocular Physiology | Oedema | 0.00 units on a scale | Standard Deviation 0 |
| Omafilcon A ll 2 | Ocular Physiology | Corneal Staining | 0.26 units on a scale | Standard Deviation 0.36 |
| Omafilcon A ll 2 | Ocular Physiology | Conjunctival Staining | 0.23 units on a scale | Standard Deviation 0.2 |
Secondary
Lens Fit - Corneal Coverage
Corneal coverage will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
Time frame: 1 week
Population: Protocol deviations and discontinuations account for difference in analysis population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A | Lens Fit - Corneal Coverage | Slightly Temporal | 0 Participants |
| Somofilcon A | Lens Fit - Corneal Coverage | Optimum | 46 Participants |
| Somofilcon A | Lens Fit - Corneal Coverage | Extremely Nasal | 0 Participants |
| Somofilcon A | Lens Fit - Corneal Coverage | Slightly Nasal | 3 Participants |
| Somofilcon A | Lens Fit - Corneal Coverage | Extremely Temporal | 0 Participants |
| Nelfilcon A II 2 | Lens Fit - Corneal Coverage | Optimum | 39 Participants |
| Nelfilcon A II 2 | Lens Fit - Corneal Coverage | Extremely Nasal | 0 Participants |
| Nelfilcon A II 2 | Lens Fit - Corneal Coverage | Slightly Nasal | 7 Participants |
| Nelfilcon A II 2 | Lens Fit - Corneal Coverage | Slightly Temporal | 2 Participants |
| Nelfilcon A II 2 | Lens Fit - Corneal Coverage | Extremely Temporal | 0 Participants |
| Omafilcon A ll 2 | Lens Fit - Corneal Coverage | Extremely Temporal | 0 Participants |
| Omafilcon A ll 2 | Lens Fit - Corneal Coverage | Slightly Temporal | 4 Participants |
| Omafilcon A ll 2 | Lens Fit - Corneal Coverage | Extremely Nasal | 0 Participants |
| Omafilcon A ll 2 | Lens Fit - Corneal Coverage | Optimum | 41 Participants |
| Omafilcon A ll 2 | Lens Fit - Corneal Coverage | Slightly Nasal | 4 Participants |
Secondary
Lens Fit - Horizontal Centration
Horizontal centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.
Time frame: 1 week
Population: Protocol deviations and discontinuations account for difference in analysis population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A | Lens Fit - Horizontal Centration | Slightly Temporal | 20 Participants |
| Somofilcon A | Lens Fit - Horizontal Centration | Optimum | 28 Participants |
| Somofilcon A | Lens Fit - Horizontal Centration | Extremely Nasal | 0 Participants |
| Somofilcon A | Lens Fit - Horizontal Centration | Slightly Nasal | 1 Participants |
| Somofilcon A | Lens Fit - Horizontal Centration | Extremely Temporal | 0 Participants |
| Nelfilcon A II 2 | Lens Fit - Horizontal Centration | Optimum | 28 Participants |
| Nelfilcon A II 2 | Lens Fit - Horizontal Centration | Extremely Nasal | 0 Participants |
| Nelfilcon A II 2 | Lens Fit - Horizontal Centration | Slightly Nasal | 3 Participants |
| Nelfilcon A II 2 | Lens Fit - Horizontal Centration | Slightly Temporal | 17 Participants |
| Nelfilcon A II 2 | Lens Fit - Horizontal Centration | Extremely Temporal | 0 Participants |
| Omafilcon A ll 2 | Lens Fit - Horizontal Centration | Extremely Temporal | 0 Participants |
| Omafilcon A ll 2 | Lens Fit - Horizontal Centration | Slightly Temporal | 22 Participants |
| Omafilcon A ll 2 | Lens Fit - Horizontal Centration | Extremely Nasal | 0 Participants |
| Omafilcon A ll 2 | Lens Fit - Horizontal Centration | Optimum | 26 Participants |
| Omafilcon A ll 2 | Lens Fit - Horizontal Centration | Slightly Nasal | 1 Participants |
Secondary
Lens Fit - Movement
Lens movement assessed using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Time frame: 1 week
Population: Protocol deviations and discontinuations account for difference in analysis population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A | Lens Fit - Movement | Slightly excessive | 8 Participants |
| Somofilcon A | Lens Fit - Movement | Optimum | 38 Participants |
| Somofilcon A | Lens Fit - Movement | Extremely inadequate | 0 Participants |
| Somofilcon A | Lens Fit - Movement | Slightly inadequate | 3 Participants |
| Somofilcon A | Lens Fit - Movement | Extremely excessive | 0 Participants |
| Nelfilcon A II 2 | Lens Fit - Movement | Optimum | 27 Participants |
| Nelfilcon A II 2 | Lens Fit - Movement | Extremely inadequate | 0 Participants |
| Nelfilcon A II 2 | Lens Fit - Movement | Slightly inadequate | 19 Participants |
| Nelfilcon A II 2 | Lens Fit - Movement | Slightly excessive | 2 Participants |
| Nelfilcon A II 2 | Lens Fit - Movement | Extremely excessive | 0 Participants |
| Omafilcon A ll 2 | Lens Fit - Movement | Extremely excessive | 1 Participants |
| Omafilcon A ll 2 | Lens Fit - Movement | Slightly excessive | 9 Participants |
| Omafilcon A ll 2 | Lens Fit - Movement | Extremely inadequate | 0 Participants |
| Omafilcon A ll 2 | Lens Fit - Movement | Optimum | 27 Participants |
| Omafilcon A ll 2 | Lens Fit - Movement | Slightly inadequate | 12 Participants |
Secondary
Lens Fit - Vertical Centration
Vertical centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
Time frame: 1 week
Population: Protocol deviations and discontinuations account for difference in analysis population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A | Lens Fit - Vertical Centration | Optimum | 21 Participants |
| Somofilcon A | Lens Fit - Vertical Centration | Extremely Nasal | 0 Participants |
| Somofilcon A | Lens Fit - Vertical Centration | Extremely Temporal | 0 Participants |
| Somofilcon A | Lens Fit - Vertical Centration | Slightly Nasal | 11 Participants |
| Somofilcon A | Lens Fit - Vertical Centration | Slightly Temporal | 17 Participants |
| Nelfilcon A II 2 | Lens Fit - Vertical Centration | Extremely Nasal | 0 Participants |
| Nelfilcon A II 2 | Lens Fit - Vertical Centration | Optimum | 22 Participants |
| Nelfilcon A II 2 | Lens Fit - Vertical Centration | Slightly Temporal | 6 Participants |
| Nelfilcon A II 2 | Lens Fit - Vertical Centration | Extremely Temporal | 0 Participants |
| Nelfilcon A II 2 | Lens Fit - Vertical Centration | Slightly Nasal | 20 Participants |
| Omafilcon A ll 2 | Lens Fit - Vertical Centration | Extremely Temporal | 0 Participants |
| Omafilcon A ll 2 | Lens Fit - Vertical Centration | Extremely Nasal | 0 Participants |
| Omafilcon A ll 2 | Lens Fit - Vertical Centration | Slightly Nasal | 22 Participants |
| Omafilcon A ll 2 | Lens Fit - Vertical Centration | Optimum | 22 Participants |
| Omafilcon A ll 2 | Lens Fit - Vertical Centration | Slightly Temporal | 5 Participants |
Secondary
Lens Surface - Deposition
Lens surface will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: 1 week
Population: Protocol deviations and discontinuations account for difference in analysis population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A | Lens Surface - Deposition | Grade 3 | 0 Participants |
| Somofilcon A | Lens Surface - Deposition | Grade 2 | 0 Participants |
| Somofilcon A | Lens Surface - Deposition | Grade 0 | 46 Participants |
| Somofilcon A | Lens Surface - Deposition | Grade 1 | 3 Participants |
| Somofilcon A | Lens Surface - Deposition | Grade 4 | 0 Participants |
| Nelfilcon A II 2 | Lens Surface - Deposition | Grade 2 | 0 Participants |
| Nelfilcon A II 2 | Lens Surface - Deposition | Grade 0 | 47 Participants |
| Nelfilcon A II 2 | Lens Surface - Deposition | Grade 1 | 1 Participants |
| Nelfilcon A II 2 | Lens Surface - Deposition | Grade 3 | 0 Participants |
| Nelfilcon A II 2 | Lens Surface - Deposition | Grade 4 | 0 Participants |
| Omafilcon A ll 2 | Lens Surface - Deposition | Grade 4 | 0 Participants |
| Omafilcon A ll 2 | Lens Surface - Deposition | Grade 3 | 0 Participants |
| Omafilcon A ll 2 | Lens Surface - Deposition | Grade 0 | 48 Participants |
| Omafilcon A ll 2 | Lens Surface - Deposition | Grade 2 | 0 Participants |
| Omafilcon A ll 2 | Lens Surface - Deposition | Grade 1 | 1 Participants |
Secondary
Lens Surface - Wettability
Lens wettability will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: 1 week
Population: Protocol deviations and discontinuations account for difference in analysis population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A | Lens Surface - Wettability | Grade 3 | 0 Participants |
| Somofilcon A | Lens Surface - Wettability | Grade 2 | 3 Participants |
| Somofilcon A | Lens Surface - Wettability | Grade 0 | 37 Participants |
| Somofilcon A | Lens Surface - Wettability | Grade 1 | 9 Participants |
| Somofilcon A | Lens Surface - Wettability | Grade 4 | 0 Participants |
| Nelfilcon A II 2 | Lens Surface - Wettability | Grade 2 | 1 Participants |
| Nelfilcon A II 2 | Lens Surface - Wettability | Grade 0 | 44 Participants |
| Nelfilcon A II 2 | Lens Surface - Wettability | Grade 1 | 3 Participants |
| Nelfilcon A II 2 | Lens Surface - Wettability | Grade 3 | 0 Participants |
| Nelfilcon A II 2 | Lens Surface - Wettability | Grade 4 | 0 Participants |
| Omafilcon A ll 2 | Lens Surface - Wettability | Grade 4 | 0 Participants |
| Omafilcon A ll 2 | Lens Surface - Wettability | Grade 3 | 0 Participants |
| Omafilcon A ll 2 | Lens Surface - Wettability | Grade 0 | 43 Participants |
| Omafilcon A ll 2 | Lens Surface - Wettability | Grade 2 | 3 Participants |
| Omafilcon A ll 2 | Lens Surface - Wettability | Grade 1 | 3 Participants |
Secondary
Visual Acuity
Visual acuity will be assessed by LogMAR.
Time frame: 1 week
Population: Protocol deviations and discontinuations account for difference in analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somofilcon A | Visual Acuity | Low Contrast | 0.18 LogMAR | Standard Deviation 0.1 |
| Somofilcon A | Visual Acuity | High Contrast | -0.11 LogMAR | Standard Deviation 0.08 |
| Nelfilcon A II 2 | Visual Acuity | Low Contrast | 0.17 LogMAR | Standard Deviation 0.11 |
| Nelfilcon A II 2 | Visual Acuity | High Contrast | -0.13 LogMAR | Standard Deviation 0.08 |
| Omafilcon A ll 2 | Visual Acuity | Low Contrast | 0.18 LogMAR | Standard Deviation 0.1 |
| Omafilcon A ll 2 | Visual Acuity | High Contrast | -0.11 LogMAR | Standard Deviation 0.07 |