Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1

Alcon

Status: Completed

Conditions: Myopia; Refractive Errors

Treatments: Device: Verofilcon A contact lenses; Device: Nesofilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT04527978

CLE383-P003

Details and patient eligibility

About

The primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Biotrue ONEday contact lenses.

Full description

Subjects are expected to attend 3 study visits and wear the PRECISION1 and Biotrue ONEday study lenses in a crossover design for approximately 8 days of exposure to each study lens type. The expected duration of subject participation is up to 22 days.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Subject must be able to understand and must sign an Institution Review Board (IRB) approved Informed Consent Form.
• Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
• Willing to wear contact lenses for at least 16 hours per day on one of the days with each lens type.
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Any ocular condition that contraindicates contact lens wear.
• Previous or current habitual wearer of PRECISION1, Biotrue ONEday, or DAILIES TOTAL1 contact lenses.
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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56 participants in 2 patient groups

PRECISION1, then Biotrue ONEday

Other group

Description:

Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.

Treatment:

Device: Nesofilcon A contact lenses

Device: Verofilcon A contact lenses

Biotrue ONEday, then PRECISION1

Other group

Description:

Nesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.

Treatment:

Device: Nesofilcon A contact lenses

Device: Verofilcon A contact lenses