Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens

Alcon

Status

Completed

Conditions

Refractive Errors

Treatments

Device: Multipurpose disinfection solution

Device: Lehfilcon A contact lenses

Study type

Interventional

Funder types

Industry

Identifiers

NCT04631796

CLY935-E006

Details and patient eligibility

About

The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 2 weeks of daily wear.

Full description

Participants will attend a Screening visit, a Dispense visit (0 to 4 days later), and a follow-up visit approximately 2 weeks after the Dispense visit.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Understand and sign an Informed Consent that has been approved by an Institutional Review Board.
Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
Willing to stop wearing habitual contact lenses for the duration of study participation.
Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Any condition that contraindicates contact lens wear, as determined by the Investigator.
Any use of systemic or ocular medications that contraindicates contact lens wear, as determined by the Investigator.
History of refractive surgery or plan to have refractive surgery during the study.
Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
Any use of topical ocular medications or artificial tear or rewetting drops that would require instillation during contact lens wear.
Monovision or multifocal contact lens wear.
Other protocol-defined exclusion criteria may apply.