Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens

Alcon Research40 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Astigmatism

Interventions

verofilcon A toric contact lensesDEVICE

Daily disposable toric soft contact lenses

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 exclusion criteria may apply.

Locations (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

Percent of lenses with axis orientation within ±30° from the intended axis, 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.

Time frame: Day 1, 10 minutes after lens insertion

Data from ClinicalTrials.gov

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