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

Alcon

Status: Completed

Conditions: Myopia; Refractive Errors

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04528017

CLE383-P004

Details and patient eligibility

About

The primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Clariti 1-Day contact lenses.

Full description

Subjects are expected to attend 3 study visits and wear the PRECISION1 and Clariti 1-Day 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 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, Clariti 1-Day, 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 Clariti 1-Day

Other group

Description:

Verofilcon A contact lenses worn first, with somofilcon 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: Somofilcon A contact lenses

Device: Verofilcon A contact lenses

Clariti 1-Day, then PRECISION1

Other group

Description:

Somofilcon 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: Somofilcon A contact lenses

Device: Verofilcon A contact lenses