Myopia
Conditions
Keywords
Lens deposits, Soft contact lens wearers
Brief summary
The purpose of this study was to measure lipid deposits on commercially marketed contact lenses when worn on an extended wear (overnight) basis for 7 days.
Interventions
Commercially marketed, silicone hydrogel contact lens
DEVICEetafilcon A contact lens (Acuvue2)
Commercially marketed, hydrogel contact lens
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
* Age 18 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. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Evidence or history of ocular conditions as prescribed in the protocol. * One functional eye or a monofit lens. * Any slit-lamp finding score of (1) at the Screening Visit as defined by the protocol. * Use of concomitant topical ocular prescription or over-the-counter ocular medications. * History of seasonal allergies with significant ocular side effects. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Front Surface Lens Deposits | 7 days | Film and discrete deposits were assessed with a slit-lamp after 2-5 hours of open eye 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
Each site enrolled normal participants (non-depositors) and depositors in approximately a 1:1 ratio, as outlined in the protocol. 54 participants in 3 US sites and 1 UK site were enrolled.
Pre-assignment details
Participants meeting eligibility criteria at the screening visit were enrolled into the study. 48 hours of no lens wear prior to Visit 1 served as the washout period. This reporting group includes all enrolled and dispensed participants.
Participants by arm
| Arm | Count |
|---|---|
| Overall This reporting group includes all enrolled and dispensed participants. | 54 |
| Total | 54 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age Continuous | 32.35 years STANDARD_DEVIATION 12.71 |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 54 | 0 / 54 |
| serious Total, serious adverse events | 0 / 54 | 0 / 54 |
Outcome results
Primary
Front Surface Lens Deposits
Film and discrete deposits were assessed with a slit-lamp after 2-5 hours of open eye 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: 7 days
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balafilcon A | Front Surface Lens Deposits | Deposits graded <2 | 20 Participants |
| Balafilcon A | Front Surface Lens Deposits | Deposits graded >1 | 34 Participants |
| Etafilcon A | Front Surface Lens Deposits | Deposits graded <2 | 25 Participants |
| Etafilcon A | Front Surface Lens Deposits | Deposits graded >1 | 29 Participants |