Clinical Performance Assessment of Two Silicone Hydrogel Daily Disposable Contact Lenses

Alcon

Status: Completed

Conditions: Myopia; Refractive Errors

Treatments: Device: LID006961 contact lens; Device: LID220365 contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT05725317

CLX679-C001

Details and patient eligibility

About

The purpose of this study is to assess the overall clinical performance of a contact lens made with a modified manufacturing process.

Full description

The expected duration of subject participation in the study is approximately 4 days with 2 scheduled visits.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Successful wearer of spherical soft contact lenses of the same brand in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
• Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
• Best corrected visual acuity (BCVA) better than or equal to 0.10 logMAR in each eye.
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during study participation.
• Wearing 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.
• Habitual monovision or multifocal contact lens wearers.
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 2 patient groups

LID220365 (OD) / LID006961 (OS)

Other group

Description:

LID220365 contact lens worn in the right eye (OD), with LID006961 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day.

Treatment:

Device: LID220365 contact lens

Device: LID006961 contact lens

LID006961 (OD) / LID220365 (OS)

Other group

Description:

LID006961 contact lens worn in the right eye (OD), with LID220365 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day.

Treatment:

Device: LID220365 contact lens

Device: LID006961 contact lens