Myopia
Conditions
Brief summary
This study is to compare the short-term clinical performance and subjective acceptance of two silicone hydrogel soft contact lenses.
Detailed description
This is a double-masked, randomized, bilateral crossover study to compare the short-term clinical performance of two silicone hydrogel soft contact lenses. Each lens type is worn for approximately six hours on separate study days, in random sequence.
Interventions
6 hours
6 hours
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. They are aged between 18 and 40 years. 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 have successfully worn contact lenses within six months of starting the study. 5. They can be satisfactorily fitted with the study contact lenses. 6. They have a contact lens spherical prescription between -0.25 to - 6.00D (inclusive) based on the ocular refraction. 7. They have a spectacle cylindrical correction of -0.75D or less in each eye based on the ocular refraction. 8. They own and habitually wear single vision spectacles. 9. They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye, with the study lenses. 10. They agree not to participate in other clinical research while enrolled on this study.
Exclusion criteria
1. They have an ocular disorder which would normally contraindicate contact lens wear. 2. They have a systemic disorder which would normally contraindicate 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 any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (eg HIV) or a history of anaphylaxis or severe allergic reaction. 9. They have grade 3 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear. 10. They have taken part in any other clinical trial or research, within two weeks prior to starting this study, which may impact on this particular work.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Lens Insertion | 6 hours | Ease of Lens Insertion is measured on a scale of 0-100 (0-Unmanageable, Lenses impossible to insert; 100-Excellent. No problems with lens insertion) |
Countries
United Kingdom
Participant flow
Pre-assignment details
Thirty-eight participants attended the initial visit with all participants completing the study.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Total study population | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 38 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 26 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 |
| other Total, other adverse events | 0 / 38 | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 |
Outcome results
Primary
Ease of Lens Insertion
Ease of Lens Insertion is measured on a scale of 0-100 (0-Unmanageable, Lenses impossible to insert; 100-Excellent. No problems with lens insertion)
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens A | Ease of Lens Insertion | 92.1 units on a scale | Standard Deviation 10.3 |
| Lens B | Ease of Lens Insertion | 90.9 units on a scale | Standard Deviation 17.4 |