Ocular Comfort
Conditions
Brief summary
The purpose of this study was to compare the fit and comfort of two types of contact lenses.
Detailed description
The relationship between ocular comfort and the Optical Coherence Tomography (OCT) measurements of post lens clearance and ocular tissue compression was studied.
Interventions
DEVICELotrafilcon A test contact lens
Silicone hydrogel single vision, soft contact lens with alternate parameters
DEVICELotrafilcon A control contact lens
Silicone hydrogel single vision, soft contact lens
DEVICEUltra-High Resolution Optical Coherence Tomographer (OCT)
Investigational, nonsignificant risk device for measuring post lens clearance and ocular tissue compression during contact lens wear
Sponsors
Bascom Palmer Eye Institute
CIBA VISION
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
* Be of legal age of consent and sign Informed Consent document. * Normal binocularity. * Be able to wear soft contact lenses. * Willing to comply with the wear and study visit schedule. * Spherical contact lens prescription within 0.50 diopter of the available lens powers. * Spectacle cylinder less than or equal to 1.50 diopter. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Eye injury or surgery within twelve weeks of enrollment. * Pre-existing ocular irritation that would preclude contact lens fitting. * Currently enrolled in any clinical trial. * Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Final Comfort | Day 2, Hour 10 | Comfort was assessed by the participant on a Visual Analog Scale of 0 to 100, where 0=Extremely Uncomfortable (My eyes are in pain. I cannot tolerate my lenses) and 100=Extremely Comfortable (My eyes feel GREAT, better than normal. I cannot feel my lenses). |
Countries
United States
Participant flow
Recruitment details
Partipants were recruited from one US study center.
Pre-assignment details
This reporting group includes all enrolled participants.
Participants by arm
| Arm | Count |
|---|---|
| Overall Each product worn bilaterally for two consecutive days in either Period One or Period Two. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age Continuous | 36.0 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Final Comfort
Comfort was assessed by the participant on a Visual Analog Scale of 0 to 100, where 0=Extremely Uncomfortable (My eyes are in pain. I cannot tolerate my lenses) and 100=Extremely Comfortable (My eyes feel GREAT, better than normal. I cannot feel my lenses).
Time frame: Day 2, Hour 10
Population: All enrolled participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon A Test | Final Comfort | 87.6 Units on a scale | Standard Deviation 10.5 |
| Lotrafilcon A Control | Final Comfort | 87.9 Units on a scale | Standard Deviation 11.1 |