Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses

Alcon Research2 sites in 1 country48 target enrollmentFebruary 5, 2020

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Refractive Errors
Sponsor: Alcon Research
Enrollment: 48
Locations: 2
Primary Endpoint: Percent of DT1 toric lenses with axis orientation within ±30° from the intended axis, 10 min after lens insertion
Status: Completed
Last Updated: 6 years ago

The purpose of this study is to evaluate the rotational behavior of DT1 Toric contact lenses.

This is a single visit, non-dispense study where subjects will be exposed to the test and control lenses for approximately 1 hour each.

Registry

clinicaltrials.gov

Start Date

February 5, 2020

End Date

March 2, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Sponsor

Responsible Party

Sponsor

•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.

•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 exclusion criteria may apply.