Refractive Error
Conditions
Keywords
Contact lens deposits, Soft contact lenses, Myopia
Brief summary
The purpose of this study was to measure front surface deposits on contact lenses when worn for ten hours.
Interventions
DEVICEBalafilcon A contact lenses (PureVision)
Commercially marketed, soft contact lenses worn bilaterally for 10 hours
DEVICEEtafilcon A contact lenses (Acuvue2)
Commercially marketed, soft contact lenses worn bilaterally for 10 hours
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older. * Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses. * Successfully wearing hydrogel or silicone hydrogel contact lenses prior to enrollment in the study. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Evidence or history of keratitis (dendritic keratitis); viral disease of the cornea and/or conjunctiva; acute bacterial disease of the cornea and/or conjunctiva and/or eyelids; infection of the eye; and/or fungal disease of the eye. * One functional eye or a monofit lens. * Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis. * Any slit-lamp finding score of (1) at the Screening Visit as defined in protocol. * Use of concomitant topical ocular prescription or over-the-counter (OTC) ocular medications. * History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Front Surface Lens Deposits | 10 hours | Film and discrete deposits were assessed with a slit-lamp after 10 hours of lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying \>25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits \<2 (less than grade 2 for both film and discrete) and into front surface lens deposits \>1 (greater than grade 1 for either film, discrete, or both). |
Countries
United States
Participant flow
Recruitment details
55 Subjects currently wearing hydrogel or silicone hydrogel lenses were recruited at 3 US and 1 United Kingdom study sites.
Pre-assignment details
Subjects randomized by lens order to wear PureVision and Acuvue 2 lenses for 10 hours each.
Participants by arm
| Arm | Count |
|---|---|
| Overall All enrolled participants | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age Continuous | 31.95 years STANDARD_DEVIATION 12.03 |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 |
Outcome results
Primary
Front Surface Lens Deposits
Film and discrete deposits were assessed with a slit-lamp after 10 hours of lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying \>25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits \<2 (less than grade 2 for both film and discrete) and into front surface lens deposits \>1 (greater than grade 1 for either film, discrete, or both).
Time frame: 10 hours
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PureVision Contact Lenses | Front Surface Lens Deposits | Deposits Graded <2 | 27 Participants |
| PureVision Contact Lenses | Front Surface Lens Deposits | Deposits Graded >1 | 28 Participants |
| Acuvue 2 Contact Lenses | Front Surface Lens Deposits | Deposits Graded <2 | 32 Participants |
| Acuvue 2 Contact Lenses | Front Surface Lens Deposits | Deposits Graded >1 | 23 Participants |