Myopia
Conditions
Brief summary
The study is to clinically evaluate currently marketed contact lenses when used in an extended wear modality of up to seven days/six nights.
Interventions
DEVICEsenofilcon A
1 week extended wear contact lens
DEVICElotrafilcon A
1 week extended wear contact lens
DEVICElotrafilcon B
1 week extended wear contact lens
DEVICEbalafilcon A
1 week extended wear contact lens
DEVICEcomfilcon A
1 week extended wear contact lens
DEVICEetafilcon A
1 week extended wear contact lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Be of legal age, and be between 18 and 39 years of age. * Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space. * Require a visual correction in both eyes (Monovision not allowed) * Require a soft contact lens spherical correction between -0.50 and -9.00D. * Have an astigmatic correction less than 1.50D in both eyes. * Be able to wear the lens powers available for this study. * Be able to regularly wear the lenses on a 7 day/6 night extended wear basis (e.g. does not regularly swim more than once a week) * Be correctable to a visual acuity of 20/30 or better in each eye. * 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. * No clinically significant slit lamp findings * No other active ocular disease. * No previous ocular surgery.
Exclusion criteria
* Requires concurrent ocular medication. * Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear. * No Clinically significant (Grade 3 or 4) slit lamp findings including corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection, or any other abnormality of the cornea that would contraindicate contact lens wear. * Diabetic. * Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV). * PMMA or RGP lens wear in the previous 8 weeks. * Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study. * Abnormal lacrimal secretions. * Pre-existing ocular irritation that would preclude contact lens fitting. * Keratoconus or other corneal irregularity. * Pregnancy, lactating or planning a pregnancy at the time of enrollment only. * Participation in any concurrent clinical trial. * Currently wearing B&L PureVision, Ciba O2 Optix, Ciba Night & Day, CooperVision Biofinity, Vistakon ACUVUE® OASYS, or Vistakon ACUVUE®2 on an EW basis * Has had previous adverse event(s) contraindicating EW e.g. MK or greater than 2 corneal scars which appear to be contact lens related (e.g. not trauma related). * Has had an eye injury or surgery within the last eight weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Corneal Infiltrative Events | 52 weeks | Extended wear is defined as 7 days, 6 nights of lens wear, weekly replacement of lenses. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type. |
| Incidence of Adverse Events | 52 weeks | Occurrence of any Adverse Event by study lens. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type. |
Countries
India
Participant flow
Pre-assignment details
There were 350 subjects recruited with 314 subjects being dispensed lenses. These 36 subjects were excluded due to failing to meet inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Senofilcon A Contact Lens ACUVUE OASYS | 55 |
| Lotrafilcon A Contact Lens NIGHT&DAY | 58 |
| Lotrafilcon B Contact Lens O2Optix | 42 |
| Balafilcon A Contact Lens PureVision | 64 |
| Comfilcon A Contact Lens Biofinity | 43 |
| Etafilcon A Contact Lens ACUVUE 2 | 52 |
| Total | 314 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 26 | 37 | 21 | 26 | 13 | 21 |
Baseline characteristics
| Characteristic | Lotrafilcon A Contact Lens | Lotrafilcon B Contact Lens | Balafilcon A Contact Lens | Senofilcon A Contact Lens | Comfilcon A Contact Lens | Etafilcon A Contact Lens | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 13 Participants | 11 Participants | 15 Participants | 11 Participants | 7 Participants | 12 Participants | 69 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 31 Participants | 49 Participants | 44 Participants | 36 Participants | 40 Participants | 245 Participants |
| Age, Continuous | 21.6 years STANDARD_DEVIATION 4.9 | 19.8 years STANDARD_DEVIATION 1.7 | 21.0 years STANDARD_DEVIATION 3.7 | 21.1 years STANDARD_DEVIATION 3.2 | 19.5 years STANDARD_DEVIATION 1.3 | 20.6 years STANDARD_DEVIATION 3.6 | 20.7 years STANDARD_DEVIATION 3.4 |
| Region of Enrollment India | 58 participants | 42 participants | 64 participants | 55 participants | 43 participants | 52 participants | 314 participants |
| Sex: Female, Male Female | 31 Participants | 25 Participants | 35 Participants | 38 Participants | 25 Participants | 26 Participants | 180 Participants |
| Sex: Female, Male Male | 27 Participants | 17 Participants | 29 Participants | 17 Participants | 18 Participants | 26 Participants | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 27 / 55 | 17 / 58 | 10 / 42 | 23 / 64 | 18 / 43 | 8 / 52 |
| serious Total, serious adverse events | 1 / 55 | 0 / 58 | 0 / 42 | 0 / 64 | 1 / 43 | 0 / 52 |
Outcome results
Primary
Incidence of Adverse Events
Occurrence of any Adverse Event by study lens. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.
Time frame: 52 weeks
Population: Subjects who were enrolled and dispensed lenses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon A Contact Lens | Incidence of Adverse Events | 35 percentage of participants |
| Lotrafilcon A Contact Lens | Incidence of Adverse Events | 24 percentage of participants |
| Lotrafilcon B Contact Lens | Incidence of Adverse Events | 19 percentage of participants |
| Balafilcon A Contact Lens | Incidence of Adverse Events | 31 percentage of participants |
| Comfilcon A Contact Lens | Incidence of Adverse Events | 37 percentage of participants |
| Etafilcon A Contact Lens | Incidence of Adverse Events | 12 percentage of participants |
Primary
Incidence of Corneal Infiltrative Events
Extended wear is defined as 7 days, 6 nights of lens wear, weekly replacement of lenses. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.
Time frame: 52 weeks
Population: Subjects who were enrolled and dispensed lenses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon A Contact Lens | Incidence of Corneal Infiltrative Events | 31 percentage of participants |
| Lotrafilcon A Contact Lens | Incidence of Corneal Infiltrative Events | 16 percentage of participants |
| Lotrafilcon B Contact Lens | Incidence of Corneal Infiltrative Events | 10 percentage of participants |
| Balafilcon A Contact Lens | Incidence of Corneal Infiltrative Events | 8 percentage of participants |
| Comfilcon A Contact Lens | Incidence of Corneal Infiltrative Events | 33 percentage of participants |
| Etafilcon A Contact Lens | Incidence of Corneal Infiltrative Events | 10 percentage of participants |