Astigmatism
Conditions
Keywords
Toric contact lens, Daily disposable, Silicone hydrogel contact lens, Axis orientation, Astigmatism
Brief summary
The purpose of this study is to obtain on-eye clinical performance data to evaluate the stability of axis orientation of DDT2 toric contact lenses in the intended population.
Detailed description
This is a single-visit, non-dispense study where subjects will be exposed to the test lenses for approximately 1 hour.
Interventions
Daily disposable toric soft contact lenses
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to understand and sign an informed consent form; * Successful wear of spherical or toric soft contact lenses in both eyes, as specified in the protocol; * Willing to NOT use rewetting/lubricating drops at any time during the study; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Any eye condition that would contraindicate contact lens wear, as determined by the Investigator; * History of eye surgery within the previous 12 months, as specified in the protocol; * Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of lenses with axis orientation within ±30° from the intended axis, 10 minutes after lens insertion | Day 1, 10 minutes after lens insertion | Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis. |
Countries
United States
Outcome results
None listed