Myopia
Conditions
Brief summary
This study was designed to gather short-term clinical performance data for 2 soft contact lenses.
Detailed description
The purpose of this participant-masked, non-randomized, crossover controlled, non-dispensing, study was to compare the short-term performance of 2 daily disposable contact lenses after 15 minutes of daily wear each. The lenses were identical in all aspects except for diameter. Participants attended for 1 visit only which lasted for approximately 2 hours.
Interventions
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
* Subjects will only be eligible for the study if: 1. They were of legal age (18) and capacity to volunteer. 2. They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent. 3. They were willing and able to follow the protocol. 4. They were wearing soft contact lenses, or had done so within the past two years. 5. They were able to be fitted with the study lenses within the power range available.
Exclusion criteria
* Subjects will not be eligible if: 1. They had an ocular disorder which would normally contra-indicate contact lens wear. 2. They had a systemic disorder which would normally contra-indicate contact lens wear. 3. They were using any topical medication such as eye drops or ointment. 4. They were aphakic. 5. They had had corneal refractive surgery. 6. They had any corneal distortion resulting from previous hard or rigid lens wear or had keratoconus. 7. They were pregnant or lactating. 8. They had an eye or health condition including an immunosuppressive or infectious disease which could, 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 had 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, unmanageable, 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=Extremely uncomfortable, 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=Extremely poor, intolerable, 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. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Continuous | 37.9 years STANDARD_DEVIATION 14.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 27 Participants | — |
| Sex: Female, Male Male | 23 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
Primary
Subjective Overall Score
Subjective overall score was assessed using 0-100 visual analogue scale, where 0=Extremely poor, unmanageable, cannot use lenses and 100=Excellent, highly impressed with these lenses overall
Time frame: 15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens 1 | Subjective Overall Score | 80.2 score on a scale | Standard Deviation 16.7 |
| Lens 2 | Subjective Overall Score | 88.2 score on a scale | Standard Deviation 11 |
Secondary
Subjective Comfort
Subjective comfort score was assessed using 0-100 visual analogue scale, where 0=Extremely uncomfortable, causes pain, cannot be tolerated and 100=Excellent, cannot be felt
Time frame: 15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens 1 | Subjective Comfort | 81.1 score on a scale | Standard Deviation 20.1 |
| Lens 2 | Subjective Comfort | 90.4 score on a scale | Standard Deviation 9.6 |
Secondary
Subjective Vision
Subjective vision score was assessed using a 0-100 visual analogue scale, where 0=Extremely poor, intolerable, lens cannot be worn and 100=Excellent, unaware of any visual loss
Time frame: 15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens 1 | Subjective Vision | 81.9 score on a scale | Standard Deviation 16.1 |
| Lens 2 | Subjective Vision | 87.2 score on a scale | Standard Deviation 12.6 |