Myopia
Conditions
Brief summary
The purpose of this study is to investigate the front surface wettability of soft contact lenses while on eye.
Interventions
DEVICElotrafilcon B
Commercially marketed, silicone hydrogel, spherical contact lens
DEVICEbalafilcon A
Commercially marketed, silicone hydrogel, spherical contact lens
DEVICEsenofilcon A
Commercially marketed, silicone hydrogel, spherical contact lens
DEVICEenfilcon A
Commercially marketed, silicone hydrogel, spherical contact lens
Sponsors
University of Waterloo
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* is at least 17 years of age * has read and signed an information consent letter * is a current daily wear contact lens wearer * has acceptable fit with the study lenses * has had an ocular exam in the last two years * other protocol-defined inclusion criteria may apply
Exclusion criteria
* has any ocular disease * has undergone corneal refractive surgery or is aphakic * has any systemic disease affecting ocular health * is pregnant or lactating * other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| On-eye Wettability | 4 weeks of wear | On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor. |
Countries
Canada
Participant flow
Recruitment details
Four participants were enrolled but not dispensed due to failing inclusion/exclusion criteria (2) and withdrawing consent (2). These participants are included in the Actual Enrollment and Baseline Characteristics calculations, but not Participant Flow.
Pre-assignment details
This reporting group includes all enrolled and dispensed participants.
Participants by arm
| Arm | Count |
|---|---|
| Overall This reporting group includes all enrolled subjects. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age Continuous | 20.0 years |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 23 | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 | 0 / 23 | 0 / 23 |
Outcome results
Primary
On-eye Wettability
On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor.
Time frame: 4 weeks of wear
Population: Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon B | On-eye Wettability | 1.33 units on a scale | Standard Deviation 1.01 |
| Balafilcon A | On-eye Wettability | 2.11 units on a scale | Standard Deviation 1.16 |
| Senofilcon A | On-eye Wettability | 1.70 units on a scale | Standard Deviation 1.09 |
| Enfilcon A | On-eye Wettability | 2.07 units on a scale | Standard Deviation 1 |