Clinical Comparison of 4 Daily Disposable Soft Contact Lenses

Alcon

Status: Completed

Conditions: Refractive Error

Treatments: Device: senofilcon A contact lenses; Device: verofilcon A contact lenses; Device: stenfilcon A contact lenses; Device: etafilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT03349632

CLE383-C004

Details and patient eligibility

About

The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population.

Full description

The expected duration of subject participation in the study is approximately 20 days with 3 scheduled visits. Each subject will evaluate the test contact lenses compared to 1 of 3 commercially available contact lenses.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to understand and must sign an approved Informed Consent Form
• Successfully wears daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months
• Best Corrected Visual Acuity of 20/25 Snellen or better in each eye
• Willing to stop wearing habitual contact lenses for the duration of study participation
• Other protocol-defined inclusion criteria may apply

Exclusion criteria

• Any eye condition, surgery, disease, or use of medication that contraindicates contact lens wear, as determined by the Investigator.
• Routinely sleeps in habitual contact lenses
• Currently wears Oasys 1-Day, MyDay, or Moist contact lenses
• Other protocol-defined exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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68 participants in 3 patient groups

DD T2/Oasys 1-Day

Other group

Description:

Verofilcon A contact lenses and senofilcon A contact lenses worn in both eyes, each product, for 1 week on a daily wear basis, as randomized

Treatment:

Device: verofilcon A contact lenses

Device: senofilcon A contact lenses

DD T2/MyDay

Other group

Description:

Verofilcon A contact lenses and stenfilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized

Treatment:

Device: stenfilcon A contact lenses

Device: verofilcon A contact lenses

DD T2/Moist

Other group

Description:

Verofilcon A contact lenses and etafilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized

Treatment:

Device: etafilcon A contact lenses

Device: verofilcon A contact lenses