Hyperopia, Myopia
Conditions
Brief summary
The aim of this study is to compare the short-term clinical performance of two soft contact lenses.
Detailed description
The aim of this study is to evaluate the short-term clinical performance of two soft contact lenses when compared to each other after 15 minutes of daily wear each.
Interventions
DEVICELens 1 (ocufilcon D)
15 minutes of daily wear
DEVICELens 2 (somofilcon A)
15 minutes of daily wear
Sponsors
CooperVision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 currently wear soft contact lenses, or have done so within the past two years. 5. They are expected to be able to be fitted with the study lenses within the power range available.
Exclusion criteria
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 are aphakic. 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 breastfeeding. 8. They have an eye or health condition including an immunosuppressive or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction. 9. They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Overall Score | At the end of 15 minutes of daily wear | The primary outcome measure for this study is the subjective overall score on a scale of 0-100 (0= Extremely poor, unmanageable, cannot use lenses, 100= Excellent, highly impressed with these lenses overall). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Vision | At the end of 15 minutes of daily wear | The secondary outcome measure for this study is the subjective vision on a scale of 0-100 (0= Extremely poor, intolerable, lenses cannot be worn, 100= Excellent, unaware of any visual loss). |
| Subjective Comfort | At the end of 15 minutes of daily wear | The secondary outcome measure for this study is the subjective comfort on a scale of 0-100 (0= Extremely uncomfortable, causes pain, cannot be tolerated, 100= Excellent, cannot be felt). |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORCarole Maldonado-Codina, PhD, FBCLA
Eurolens Research
Participant flow
Pre-assignment details
Fifty Two participants were screened. All the participants who were eligible (n=50) in the study were included in the analysis.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 41.3 Years STANDARD_DEVIATION 14.9 |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
None listed