Myopia
Conditions
Brief summary
This will be a 1-month dispensing, double-masked, randomized, contralateral study comparing the test lens against the control lens. The assignment of lenses to eyes (i.e. which lens type is to be worn in which eye throughout the study) will be selected according to a randomization table.
Detailed description
Both test and control lenses will be used in a daily wear modality for 1 month. It is anticipated that this study will involve the following visits: Baseline (screening and dispense visit combined), 2-week visit and 4-week visit.
Interventions
DEVICESapphire Lens
Each subject randomized to wear either the test or control in either the left of right eye.
DEVICEenfilcon A
Each subject randomized to wear either the test or control in either the left of right eye.
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Is at least 17 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 20/30 or better (in each eye) with their habitual correction or the assigned study lenses * Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day.)
Exclusion criteria
* Is participating in any concurrent clinical or research study * Has any known active\* ocular disease and/or infection; * Has a systemic condition that in the opinion of the investigator may affect a study outcome variable * Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable\^ * Has known sensitivity to the diagnostic pharmaceuticals to be used in the study * Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit). Rationale is that systemic changes over time due to pregnancy/lactating may adversely affect contact lens wear e.g. ocular dryness may increase. * Is aphakic * Has undergone corneal refractive surgery. For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active. Participants will be excluded with significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 3 or above: corneal edema, tarsal abnormalities, and conjunctival injection) or active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology). \^ For the purposes of this study, participants will be excluded, if currently taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Ratings of Comfort | Baseline (After 10 minutes of lens dispense) | Subjective ratings of Comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever |
| Subjective Comfort Preference | Baseline (after 10 minutes of lens dispense) | Subjective comfort preference Sapphire lens, Enfilcon A, no preference |
| Lens Wettability | Baseline (After 10 minutes of lens dispense) | Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced) |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month.
Sapphire Lens: Contact lens. Enfilcon A: contact lens | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 17 Participants | — |
| Age, Continuous | 28 years STANDARD_DEVIATION 10 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 17 participants | — |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
Primary
Lens Wettability
Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sapphire Lens | Lens Wettability | 2.9 units on a scale | Standard Deviation 0.9 |
| Enfilcon A | Lens Wettability | 2.6 units on a scale | Standard Deviation 1 |
Primary
Lens Wettability
Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)
Time frame: Baseline (After 10 minutes of lens dispense)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sapphire Lens | Lens Wettability | 2.9 units on a scale | Standard Deviation 0.7 |
| Enfilcon A | Lens Wettability | 2.6 units on a scale | Standard Deviation 1 |
Primary
Lens Wettability
Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sapphire Lens | Lens Wettability | 2.8 units on a scale | Standard Deviation 1 |
| Enfilcon A | Lens Wettability | 2.8 units on a scale | Standard Deviation 0.8 |
Primary
Subjective Comfort Preference
Subjective comfort preference Sapphire lens, Enfilcon A, no preference
Time frame: 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire Lens | Subjective Comfort Preference | Sapphire lens | 53 percentage of eyes |
| Sapphire Lens | Subjective Comfort Preference | enfilcon A | 18 percentage of eyes |
| Sapphire Lens | Subjective Comfort Preference | No preference | 29 percentage of eyes |
Primary
Subjective Comfort Preference
Subjective comfort preference Sapphire lens, Enfilcon A, no preference
Time frame: Baseline (after 10 minutes of lens dispense)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire Lens | Subjective Comfort Preference | Sapphire lens | 47 percentage of eyes |
| Sapphire Lens | Subjective Comfort Preference | enfilcon A | 12 percentage of eyes |
| Sapphire Lens | Subjective Comfort Preference | No preference | 41 percentage of eyes |
Primary
Subjective Comfort Preference
Subjective comfort preference Sapphire lens, Enfilcon A, no preference
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire Lens | Subjective Comfort Preference | Sapphire lens | 47 percentage of eyes |
| Sapphire Lens | Subjective Comfort Preference | enfilcon A | 18 percentage of eyes |
| Sapphire Lens | Subjective Comfort Preference | No preference | 35 percentage of eyes |
Primary
Subjective Ratings of Comfort
Subjective ratings of Comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever
Time frame: Baseline (After 10 minutes of lens dispense)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sapphire Lens | Subjective Ratings of Comfort | 92 units on a scale | Standard Deviation 9 |
| Enfilcon A | Subjective Ratings of Comfort | 91 units on a scale | Standard Deviation 9 |
Primary
Subjective Ratings of Comfort
Subjective ratings of Comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sapphire Lens | Subjective Ratings of Comfort | 81 units on a scale | Standard Deviation 16 |
| Enfilcon A | Subjective Ratings of Comfort | 80 units on a scale | Standard Deviation 14 |
Primary
Subjective Ratings of Comfort
Subjective ratings of Comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sapphire Lens | Subjective Ratings of Comfort | 80 units on a scale | Standard Deviation 18 |
| Enfilcon A | Subjective Ratings of Comfort | 82 units on a scale | Standard Deviation 8 |