Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens

Alcon

Status: Completed

Conditions: Astigmatism

Treatments: Device: verofilcon A toric contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT04464044

CLA306-C003

Details and patient eligibility

About

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.

Full description

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

DDT2 Toric

Experimental group

Description:

Verofilcon A toric contact lenses worn in both eyes

Treatment:

Device: verofilcon A toric contact lenses