Clinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact Lens

Alcon

Status: Completed

Conditions: Refractive Errors

Treatments: Device: LID021201 contact lenses; Device: OPTI-FREE multipurpose solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04702984

CLL949-E003

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 7 days of daily wear.

Full description

Participants will attend a Screening visit, a Dispense visit, and a Week 1 Follow-up/exit visit.

Enrollment: 39 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 daily wear frequent replacement 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.
• Wears 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.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

LID021201

Experimental group

Description:

LID021201 contact lenses worn in both eyes for 7 days. Lenses will be removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution.

Treatment:

Device: OPTI-FREE multipurpose solution

Device: LID021201 contact lenses