Hyperopia, Myopia
Conditions
Brief summary
The study objective was to gather short-term clinical performance data for two soft contact lenses.
Detailed description
The aim of this subject-masked, non-randomized, controlled non-dispensing study was to evaluate the short-term clinical performance of a monthly sphere contact lens when compared to a daily disposable contact lens after 15 minutes of daily wear each.
Interventions
DEVICELens 1 (monthly replacement)
Monthly replacement spherical silicone hydrogel contact lens for 15 minutes
DEVICELens 2 (daily disposable)
Daily disposable spherical silicone hydrogel contact lens for 15 minutes
Sponsors
CooperVision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
All participants received Lens 1 and then Lens 2 in fixed-sequence order.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 currently wear soft contact lenses, or have done so within the past two years. * They are expected to be able to be fitted with the study lenses within the power range available.
Exclusion criteria
* 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 are aphakic. * 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 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. * 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 | 15 minutes | Subjective overall score was assessed using 0-100 visual analogue scale, where 0=Extremely poor, cannot use lenses and 100=Excellent, highly impressed with these lenses overall |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Comfort | 15 minutes | Subjective comfort score was assessed using 0-100 visual analogue scale, where 0=Causes pain, cannot be tolerated and 100=Excellent, cannot be felt |
| Subjective Vision | 15 minutes | Subjective vision score was assessed using a 0-100 visual analogue scale, where 0=Unacceptable, lens cannot be worn and 100=Excellent, unaware of any visual loss |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study All participants who participated in the clinical trial. | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Continuous Female | 32.4 years STANDARD_DEVIATION 11.9 | — |
| Age, Continuous Male | 37.3 years STANDARD_DEVIATION 15 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 28 Participants | — |
| Sex: Female, Male Male | 17 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 0 / 45 | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
Subjective Overall Score
Subjective overall score was assessed using 0-100 visual analogue scale, where 0=Extremely poor, cannot use lenses and 100=Excellent, highly impressed with these lenses overall
Time frame: 15 minutes
Population: One participant was excluded from data analysis due to issues during lens application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens 1 | Subjective Overall Score | 84.7 score on a scale | Standard Deviation 15.5 |
| Lens 2 | Subjective Overall Score | 82.5 score on a scale | Standard Deviation 14.6 |
Secondary
Subjective Comfort
Subjective comfort score was assessed using 0-100 visual analogue scale, where 0=Causes pain, cannot be tolerated and 100=Excellent, cannot be felt
Time frame: 15 minutes
Population: One participant was excluded from data analysis due to issues during lens application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens 1 | Subjective Comfort | 86.4 score on a scale | Standard Deviation 16.4 |
| Lens 2 | Subjective Comfort | 86.6 score on a scale | Standard Deviation 13.5 |
Secondary
Subjective Vision
Subjective vision score was assessed using a 0-100 visual analogue scale, where 0=Unacceptable, lens cannot be worn and 100=Excellent, unaware of any visual loss
Time frame: 15 minutes
Population: One participant was excluded from data analysis due to issues during lens application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens 1 | Subjective Vision | 85.8 score on a scale | Standard Deviation 14.9 |
| Lens 2 | Subjective Vision | 82.7 score on a scale | Standard Deviation 15.9 |