Myopia, Refractive Error
Conditions
Keywords
Contact lenses, Myopia
Brief summary
The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2 days of wearing of each product.
Interventions
Silicone hydrogel contact lenses (8.5 and 8.8 base curves) dispensed per manufacturer's guidelines for daily disposable wear
Silicone hydrogel contact lenses (8.5 and 9.0 base curves) dispensed per manufacturer's guidelines for daily disposable wear
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign Informed Consent document. * Habitually wear soft contact lenses on a daily disposable or weekly/monthly replacement basis. * Symptoms of contact lens discomfort as defined by protocol. * Require contact lenses within the power range of -0.50 diopter (D) to -10.00 D. * Cylinder, if present, less or equal to 0.75D in either eyes at Visit 1. * Vision correctable to 20/25 or 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1. * Acceptable contact lens fit with both study contact lenses. * Willing to wear lenses every day for at least for a minimum of five days per week six hours per day, every day if possible and attend all study visits. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Currently wearing DT1 or 1DAVTE. * Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear. * Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator. * Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial. * Any moderate or severe ocular condition observed during the slit-lamp examination at the enrollment visit. * History of herpetic keratitis, ocular surgery or irregular cornea. * Prior refractive surgery (e.g. LASIK, PRK, etc). * Monocular subjects (only one eye with functional vision) or subjects fit with only one lens. * Judged ineligible as a patient in this clinical study by the investigator. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate of Lens Centration After 7 ± 2 Days of Wear | Day 7, each product | Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as optimal or slight decentration. One eye (study eye) was analyzed. |
Countries
Japan
Participant flow
Recruitment details
Subjects were recruited from 3 study centers located in Japan.
Pre-assignment details
Of the 53 enrolled, 6 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (47).
Participants by arm
| Arm | Count |
|---|---|
| Overall DAILIES TOTAL1® and 1-Day Acuvue® TruEye® contact lenses worn during Period 1 and Period 2 in a crossover assignment. | 47 |
| Total | 47 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 37.0 years STANDARD_DEVIATION 9.6 |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 47 | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 | 0 / 47 |
Outcome results
Primary
Success Rate of Lens Centration After 7 ± 2 Days of Wear
Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as optimal or slight decentration. One eye (study eye) was analyzed.
Time frame: Day 7, each product
Population: This analysis population includes all subjects who used the study lenses and who met all inclusion criteria and did not meet any exclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dailies Total 1 | Success Rate of Lens Centration After 7 ± 2 Days of Wear | 100.0 percentage of subjects |
| 1DAVTE | Success Rate of Lens Centration After 7 ± 2 Days of Wear | 86.7 percentage of subjects |