Myopia
Conditions
Brief summary
The objective of the study is to evaluate and compare the performance of study test lens to study control lens, when worn on a daily disposable modality over a period of approximately one week each
Detailed description
The study is a prospective, double masked (investigator and participant), bilateral, randomized,one week cross-over dispensing study, which evaluates the study test lens and control lens.
Interventions
DEVICETest Contact Lens
Subjects will be randomized to wear test lenses.
DEVICEControl Contact Lens
Subjects will be randomized to wear control lenses.
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Is at least 17 years of age and has full legal capacity to volunteer; 2. Has read and signed an information consent letter; 3. Is willing and able to follow instructions and maintain the appointment schedule; 4. Habitually wears soft contact lenses in daily wear, for minimum of 6-months; 5. Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses; 6. Has an astigmatism of ≤ 1.00 D in subjective refraction; 7. Can be fit with study contact lenses with a power between -2.00 and -5.00 DS; 8. Demonstrates an acceptable fit with the study lenses; 9. Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a week, and is willing to wear contact lenses for at least 12 hours a day in the study.
Exclusion criteria
1. Is participating in any concurrent clinical or research study; 2. Has any known active\* ocular disease and/or infection; 3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; 6. Is pregnant, lactating or planning a pregnancy at the time of enrolment because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. Verbal confirmation at the screening visit is sufficient; 7. Is aphakic; 8. Has undergone refractive error surgery; 9. Is an employee of the Centre for Ocular Research & Education; 10. Has participated in the BOXER (i.e. EX-MKTG-107, phases 1 or 2) or BASSET (EXMKTG-113) Study; 11. Has participated in any clinical trials within a week prior to the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Lens Fit Acceptance | 1 week | Overall fit acceptance (0-4, 0.50 steps) (0 - lens should not be worn at all,1 - Borderline but unacceptable, 2 - Minimally acceptable, 3 - Not perfect but OK to dispense, 4 - Perfect) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Centration | Baseline | Lens Centration was measured on a scale (0-3) (0 = Optimally centered, 1 = Slightly decentered, 2 = Moderate decentration but not encroaching limbus, 3 = Excessive & occasionally encroaching limbus) |
| Post-blink Movement | Baseline | Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps |
| Push-up Tightness | Baseline | Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement) |
Countries
Canada
Participant flow
Pre-assignment details
Forty-one subjects were screened and 35 subjects started and completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Subjects will be randomized to wear control lenses and test lenses for one week.
Contact lenses: Test Contact Lens Contact lenses: Control Contact Lens | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 2 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 39 Participants | — |
| Age, Continuous | 25.8 years STANDARD_DEVIATION 9.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 41 participants | — |
| Sex: Female, Male Female | 31 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
Overall Lens Fit Acceptance
Overall fit acceptance (0-4, 0.50 steps) (0 - lens should not be worn at all,1 - Borderline but unacceptable, 2 - Minimally acceptable, 3 - Not perfect but OK to dispense, 4 - Perfect)
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lens | Overall Lens Fit Acceptance | 3.71 units on a scale | Standard Deviation 0.33 |
| Control Contact Lens | Overall Lens Fit Acceptance | 3.73 units on a scale | Standard Deviation 0.35 |
Secondary
Lens Centration
Lens Centration was measured on a scale (0-3) (0 = Optimally centered, 1 = Slightly decentered, 2 = Moderate decentration but not encroaching limbus, 3 = Excessive & occasionally encroaching limbus)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lens | Lens Centration | 0.40 units on a scale | Standard Deviation 0.5 |
| Control Contact Lens | Lens Centration | 0.29 units on a scale | Standard Deviation 0.52 |
Secondary
Lens Centration
Lens Centration was measured on a scale (0-3) (0 = Optimally centered, 1 = Slightly decentered, 2 = Moderate decentration but not encroaching limbus, 3 = Excessive & occasionally encroaching limbus)
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lens | Lens Centration | 0.17 units on a scale | Standard Deviation 0.38 |
| Control Contact Lens | Lens Centration | 0.20 units on a scale | Standard Deviation 0.47 |
Secondary
Post-blink Movement
Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lens | Post-blink Movement | 0.20 mm | Standard Deviation 0.06 |
| Control Contact Lens | Post-blink Movement | 0.23 mm | Standard Deviation 0.06 |
Secondary
Post-blink Movement
Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lens | Post-blink Movement | 0.20 mm | Standard Deviation 0.05 |
| Control Contact Lens | Post-blink Movement | 0.23 mm | Standard Deviation 0.07 |
Secondary
Push-up Tightness
Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lens | Push-up Tightness | 51 units on a scale | Standard Deviation 5 |
| Control Contact Lens | Push-up Tightness | 49 units on a scale | Standard Deviation 6 |
Secondary
Push-up Tightness
Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum and 100% = no movement)
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lens | Push-up Tightness | 50 units on a scale | Standard Deviation 4 |
| Control Contact Lens | Push-up Tightness | 48 units on a scale | Standard Deviation 4 |