Refractive Errors
Conditions
Keywords
toric contact lens, daily disposable, silicone hydrogel contact lens, axis orientation, astigmatism
Brief summary
The purpose of this study is to evaluate the rotational behavior of DT1 Toric contact lenses.
Detailed description
This is a single visit, non-dispense study where subjects will be exposed to the test and control lenses for approximately 1 hour each.
Interventions
DEVICEDT1 Toric contact lenses
Delefilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia)
DEVICEAO1DfA contact lenses
Senofilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia)
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current wearer of any commercial soft daily wear contact lens with at least 3 months of wearing experience with a minimum wearing time of 5 days per week and 8 hours per day. * Requiring contact lens (manifest refraction) of a cylindrical power of -0.75 to -2.50 diopter cylinder (DC). * Best corrected distance visual acuity 20/25 or better Snellen in each eye (as determined by manifest refraction at screening). * Willing to NOT use rewetting/lubricating drops at any time during the study. Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator. * Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator. * History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye. * Eye injury in either eye within 12 weeks immediately prior to enrollment for this trial. Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of DT1 toric lenses with axis orientation within ±30° from the intended axis, 10 min after lens insertion | Day 1, 10 minutes after lens insertion, each product | A slit lamp will be used to observe axis orientation. |
Countries
United States
Outcome results
None listed