Myopia
Conditions
Brief summary
Evaluation of Comfilcon A and Senofilcon A Lenses
Detailed description
Non-dispensing, single-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.
Interventions
DEVICESenofilcon A; Comfilcon A
Senofilcon A; Comfilcon A
DEVICEComfilcon A; Senofilcon A
Comfilcon A; Senofilcon A
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must satisfy the following conditions prior to inclusion in the study: * Has had an 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 20/30 or better (in each eye) with their habitual vision correction * Currently wears soft contact lenses at least 3 days a week, 8 hours a day * Has clear corneas and no active ocular disease * Has not worn lenses for at least 12 hours before the examination * Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: * No amblyopia * No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes) * No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection). * No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea \[infiltrates\], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology) * No aphakia * Has prescription to match the available power range.
Exclusion criteria
Any of the following will render a subject ineligible for inclusion: * Greater than 0.75 of refractive astigmatism in either eye * Has never worn contact lenses before * Wears contact lenses on an extended wear basis * Has any systemic disease affecting ocular health * Is a known sufferer of ocular allergies * Is 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 * Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities * Is aphakic * Has undergone corneal refractive surgery. * Is wearing monovision * Is participating in any other type of clinical or research study * Female who is currently pregnant or is breast-feeding * Has \> grade 1 ocular corneal staining in both type and extent by \> grade 2 in either type or extent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Responses for Comfort Rated on a 0-100 Visual Scale. | Baseline Insertion, 10 Minutes, 5 hours and 10 hours | Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever) |
Countries
United States
Participant flow
Pre-assignment details
Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye. The subject is expected to attend the baseline visit not wearing their habitual contact lens products for at least 12 hours.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Participants Senofilcon A and Comfilcon A | 61 |
| Total | 61 |
Baseline characteristics
| Characteristic | Overall Study Participants |
|---|---|
| Age, Continuous | 26 years STANDARD_DEVIATION 6 |
| Age, Customized <=18 years | 0 eyes |
| Age, Customized >=65 years | 0 eyes |
| Age, Customized Between 18 and 65 years | 61 eyes |
| Region of Enrollment United States | 61 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 61 | 0 / 61 |
| serious Total, serious adverse events | 0 / 61 | 0 / 61 |
Outcome results
Primary
Subjective Responses for Comfort Rated on a 0-100 Visual Scale.
Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)
Time frame: Baseline Insertion, 10 Minutes, 5 hours and 10 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A | Subjective Responses for Comfort Rated on a 0-100 Visual Scale. | Baseline Insertion | 86 units on a scale | Standard Deviation 15 |
| Comfilcon A | Subjective Responses for Comfort Rated on a 0-100 Visual Scale. | 10 Minutes | 89 units on a scale | Standard Deviation 14 |
| Comfilcon A | Subjective Responses for Comfort Rated on a 0-100 Visual Scale. | 5 Hours | 83 units on a scale | Standard Deviation 19 |
| Comfilcon A | Subjective Responses for Comfort Rated on a 0-100 Visual Scale. | 10 Hours | 79 units on a scale | Standard Deviation 23 |
| Senofilcon A | Subjective Responses for Comfort Rated on a 0-100 Visual Scale. | 10 Hours | 81 units on a scale | Standard Deviation 21 |
| Senofilcon A | Subjective Responses for Comfort Rated on a 0-100 Visual Scale. | Baseline Insertion | 87 units on a scale | Standard Deviation 13 |
| Senofilcon A | Subjective Responses for Comfort Rated on a 0-100 Visual Scale. | 5 Hours | 84 units on a scale | Standard Deviation 18 |
| Senofilcon A | Subjective Responses for Comfort Rated on a 0-100 Visual Scale. | 10 Minutes | 91 units on a scale | Standard Deviation 12 |