Myopia
Conditions
Brief summary
The purpose of this study is to assess the ophthalmic compatibility of three different silicone hydrogel lenses worn on an overnight basis for six nights.
Interventions
Investigational, silicone hydrogel, spherical soft contact lens
Commercially marketed, silicone hydrogel, spherical soft contact lens
DEVICEGalyfilcon A contact lens
Commercially marketed, silicone hydrogel, spherical soft contact lens
Sponsors
University of Waterloo
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is at least 17 years of age and has full legal capacity to volunteer * Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction * Has had an ocular examination in the last two years * Is a current soft (hydrogel or silicone hydrogel) contact lens wearer * Has clear corneas and no active ocular disease * Can be successfully fit with the lenses to be used in the study * Other protocol-defined inclusion/
Exclusion criteria
may apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Front Surface Lens Deposits | Period 2, Day 6 | Protein and lipid deposits on the contact lens surface as assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4 with 0 being none and 4 being severe. |
Countries
Canada
Participant flow
Pre-assignment details
Of the 57 subjects screened for the study, 11 did not start Period 1 due to personal reasons (7) and non-suitability (4). Period 1 established Day One measurements in order to monitor changes during Period 2.
Participants by arm
| Arm | Count |
|---|---|
| Overall This reporting group includes all subjects who were screened for the study, whether or not they subsequently were dispensed. | 57 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Period 1, One Night of Wear | Personal Reasons | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age Continuous | 23.23 years STANDARD_DEVIATION 4.04 |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Front Surface Lens Deposits
Protein and lipid deposits on the contact lens surface as assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4 with 0 being none and 4 being severe.
Time frame: Period 2, Day 6
Population: Per Protocol. Only the data from participants who completed all study visits were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon A | Front Surface Lens Deposits | 0.68 Units on a Scale | Standard Deviation 0.35 |
| Narafilcon A | Front Surface Lens Deposits | 0.78 Units on a Scale | Standard Deviation 0.67 |
| Galyfilcon A | Front Surface Lens Deposits | 0.77 Units on a Scale | Standard Deviation 0.61 |