Myopia
Conditions
Brief summary
Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed lens (control), when worn on a daily basis for 1 month.
Detailed description
Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed silicone- hydrogel contact lens (control), when worn on a daily basis for 1 month.
Interventions
DEVICETest lens
Contact lens
DEVICEControl lens
Contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This will be a double-masked study in which both participant and investigator will be masked.
Intervention model description
Each subject will be randomized to wear the test or control contact lens for 1 month and then crossed-over to wear the other contact lens for 1 month.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has had a self-reported oculo-visual examination in the last two years. * Is at least 18 years of age and has full legal capacity to volunteer. * Has read and understood the information consent letter. * Is willing and able to follow instructions and maintain the appointment schedule. * Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected. * Currently wears soft contact lenses. * Requires spectacle lens powers between -0.75 to -6.50 diopters sphere (0.25D steps). * Has no more than 0.75 diopters of refractive astigmatism. * Has clear corneas and no active ocular disease. * Has not worn lenses for at least 12 hours before the examination. * Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit
Exclusion criteria
* Has never worn contact lenses before. * Has any systemic disease affecting ocular health. * Is using any systemic or topical medications that will affect ocular health. * Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. * Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. * Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. * Is aphakic. * Has undergone corneal refractive surgery. * Is participating in any other type of eye related clinical or research study. * Known allergy to a product used in this study (ex. Shellfish allergy) * Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Surface Wettability | Baseline | Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \<\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time) |
| Lens Surface Deposits | Baseline | Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits, 1: 5 or less small deposits (\<0.1mm), 2: \>5 deposits of \<0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface) |
| Overall Lens Fit Acceptance | Baseline | Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum) |
| Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Baseline | Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\<0.5mm), Extremely decentered (\>0.5mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bulbar Conjunctiva Hyperaemia | Baseline | Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection) |
| Limbal Conjunctiva Hyperaemia | Baseline | Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Total participants | 58 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Physician Decision | 2 | 1 |
| First Intervention | Withdrawal by Subject | 3 | 6 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 58 Participants | — |
| Age, Continuous | 27 years STANDARD_DEVIATION 6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 58 participants | — |
| Sex: Female, Male Female | 44 Participants | — |
| Sex: Female, Male Male | 14 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 46 |
| other Total, other adverse events | 0 / 46 | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 | 0 / 46 |
Outcome results
Primary
Lens Surface Deposits
Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (\<0.1mm), 2: \>5 deposits of \<0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface)
Time frame: 4-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Lens Surface Deposits | 0.35 units on a scale | Standard Deviation 0.54 |
| Control Lens | Lens Surface Deposits | 0.38 units on a scale | Standard Deviation 0.63 |
Primary
Lens Surface Deposits
Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (\<0.1mm), 2: \>5 deposits of \<0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface).
Time frame: 2-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Lens Surface Deposits | 0.30 units on a scale | Standard Deviation 0.6 |
| Control Lens | Lens Surface Deposits | 0.26 units on a scale | Standard Deviation 0.53 |
Primary
Lens Surface Deposits
Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits, 1: 5 or less small deposits (\<0.1mm), 2: \>5 deposits of \<0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Lens Surface Deposits | 0.02 units on a scale | Standard Deviation 0.12 |
| Control Lens | Lens Surface Deposits | 0.04 units on a scale | Standard Deviation 0.23 |
Primary
Lens Surface Wettability
Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \<\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Lens Surface Wettability | 3.26 units on a scale | Standard Deviation 0.48 |
| Control Lens | Lens Surface Wettability | 3.26 units on a scale | Standard Deviation 0.44 |
Primary
Lens Surface Wettability
Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \<\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
Time frame: 4-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Lens Surface Wettability | 3.11 units on a scale | Standard Deviation 0.51 |
| Control Lens | Lens Surface Wettability | 3.01 units on a scale | Standard Deviation 0.62 |
Primary
Lens Surface Wettability
Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \<\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
Time frame: 2-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Lens Surface Wettability | 3.18 units on a scale | Standard Deviation 0.53 |
| Control Lens | Lens Surface Wettability | 3.25 units on a scale | Standard Deviation 0.47 |
Primary
Overall Lens Fit Acceptance
Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)
Time frame: 4-Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Overall Lens Fit Acceptance | 3.31 units on a scale | Standard Deviation 0.36 |
| Control Lens | Overall Lens Fit Acceptance | 3.13 units on a scale | Standard Deviation 0.53 |
Primary
Overall Lens Fit Acceptance
Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Overall Lens Fit Acceptance | 3.30 units on a scale | Standard Deviation 0.33 |
| Control Lens | Overall Lens Fit Acceptance | 3.27 units on a scale | Standard Deviation 0.35 |
Primary
Overall Lens Fit Acceptance
Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)
Time frame: 2-Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Overall Lens Fit Acceptance | 3.28 units on a scale | Standard Deviation 0.41 |
| Control Lens | Overall Lens Fit Acceptance | 3.31 units on a scale | Standard Deviation 0.35 |
Primary
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\<0.5mm), Extremely decentered (\>0.5mm)
Time frame: 4-weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test Lens | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Optimal | 59 percentage of participants |
| Test Lens | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Slightly Decentered | 40 percentage of participants |
| Test Lens | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Extremely Decentered | 1 percentage of participants |
| Control Lens | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Optimal | 33 percentage of participants |
| Control Lens | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Slightly Decentered | 59 percentage of participants |
| Control Lens | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Extremely Decentered | 8 percentage of participants |
Primary
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\<0.5mm), Extremely decentered (\>0.5mm)
Time frame: 2-weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test Lens | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Optimal | 57 percentage of participants |
| Test Lens | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Slightly Decentered | 43 percentage of participants |
| Test Lens | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Extremely Decentered | 0 percentage of participants |
| Control Lens | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Optimal | 40 percentage of participants |
| Control Lens | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Slightly Decentered | 52 percentage of participants |
| Control Lens | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Extremely Decentered | 8 percentage of participants |
Primary
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\<0.5mm), Extremely decentered (\>0.5mm)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test Lens | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Optimal | 49 percentage of participants |
| Test Lens | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Slightly Decentered | 45 percentage of participants |
| Test Lens | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Extremely Decentered | 6 percentage of participants |
| Control Lens | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Optimal | 38 percentage of participants |
| Control Lens | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Slightly Decentered | 55 percentage of participants |
| Control Lens | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Extremely Decentered | 7 percentage of participants |
Secondary
Bulbar Conjunctiva Hyperaemia
Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Bulbar Conjunctiva Hyperaemia | 1.11 units on a scale | Standard Deviation 0.49 |
| Control Lens | Bulbar Conjunctiva Hyperaemia | 1.11 units on a scale | Standard Deviation 0.49 |
Secondary
Bulbar Conjunctiva Hyperaemia
Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time frame: 4-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Bulbar Conjunctiva Hyperaemia | 1.15 units on a scale | Standard Deviation 0.47 |
| Control Lens | Bulbar Conjunctiva Hyperaemia | 1.27 units on a scale | Standard Deviation 0.43 |
Secondary
Bulbar Conjunctiva Hyperaemia
Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time frame: 2-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Bulbar Conjunctiva Hyperaemia | 1.20 units on a scale | Standard Deviation 0.45 |
| Control Lens | Bulbar Conjunctiva Hyperaemia | 1.23 units on a scale | Standard Deviation 0.43 |
Secondary
Limbal Conjunctiva Hyperaemia
Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Limbal Conjunctiva Hyperaemia | 0.57 units on a scale | Standard Deviation 0.35 |
| Control Lens | Limbal Conjunctiva Hyperaemia | 0.57 units on a scale | Standard Deviation 0.35 |
Secondary
Limbal Conjunctiva Hyperaemia
Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time frame: 4-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Limbal Conjunctiva Hyperaemia | 0.65 units on a scale | Standard Deviation 0.42 |
| Control Lens | Limbal Conjunctiva Hyperaemia | 0.76 units on a scale | Standard Deviation 0.35 |
Secondary
Limbal Conjunctiva Hyperaemia
Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time frame: 2-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Limbal Conjunctiva Hyperaemia | 0.71 units on a scale | Standard Deviation 0.4 |
| Control Lens | Limbal Conjunctiva Hyperaemia | 0.63 units on a scale | Standard Deviation 0.39 |