Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Toric Contact Lenses

Not Applicable

Completed

Brief Summary: The primary objective of this study is to evaluate the axis orientation of LID226397 toric contact lenses.

Detailed Description: Subjects will be expected to attend 7 visits including a screening visit. The total duration of a subject's participation in the study will be approximately 40 days.

Recruitment & Eligibility

Inclusion Criteria

Successful wearers of any commercial soft toric contact lenses (except AOfAHP and daily disposable lenses) in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
Able to be fit with and wear contact lenses within the available range of sphere & cylinder power and axes.
Best corrected distance visual acuity greater than or equal to 20/25 Snellen (0.10 logMAR) in each eye as determined by manifest refraction at screening.
Other protocol-defined inclusion criteria may apply.

Key

Exclusion Criteria

Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
Habitual AOfAHP contact lens wearers and habitual daily disposable lens wearers (worn within last 3 months).
Other exclusion criteria may apply.

Primary Outcome Measures

Name	Time	Method
Percentage of Lenses With Axis Orientation Within Plus or Minus 30 Degrees From the Intended Axis at 10 Minutes After Lens Insertion	Day 1 Dispense, 10 minutes after lens insertion, for each wear period. Each wear period is approximately 14 days according to randomization assignment.	The investigator will view the contact lens through a slit lamp (biomicroscope) and record the axis orientation (-179° to +180°) as the number of degrees away from the ideal location (90° axis) either positive or negative depending on the direction (nasal \[+\] or temporal \[-\]). No hypothesis testing was prespecified for this endpoint.

Secondary Outcome Measures

Name	Time	Method

Locations (7): Dr. Elsa Pao, OD
🇺🇸
Oakland, California, United States
Pacific Rims Optometry
🇺🇸
San Francisco, California, United States
Drs. Giedd, P.A.
🇺🇸
Maitland, Florida, United States
Vision Health Institute
🇺🇸
Orlando, Florida, United States
Franklin Park Eye Center, PC
🇺🇸
Franklin Park, Illinois, United States
ProCare Vision Centers, Inc.
🇺🇸
Granville, Ohio, United States
Optometry Group, PLLC
🇺🇸
Memphis, Tennessee, United States
Dr. Elsa Pao, OD
🇺🇸Oakland, California, United States