Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 2

Alcon

Status: Completed

Conditions: Myopia; Refractive Error

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03888482

CLE383-C010

Details and patient eligibility

About

The purpose of this study was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Clariti contact lenses.

Full description

Subjects were expected to attend 3 study visits and wear the DDT2 and Clariti study lenses in a crossover design for approximately 14 - 20 days (7 - 10 days for each product).

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Able to understand and sign an Informed Consent Form that has been approved by an Institutional Review Board.
• Willing and able to attend all scheduled study visits as required per protocol.
• Current wearer of spherical soft contact lenses.

Key Exclusion Criteria:

• Any ocular condition that contraindicates contact lens wear.
• Previous or current habitual wearer of clariti® or DAILIES TOTAL1® contact lenses.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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154 participants in 2 patient groups

DDT2, then Clariti

Other group

Description:

Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.

Treatment:

Device: Somofilcon A contact lenses

Device: Verofilcon A contact lenses

Clariti, then DDT2

Other group

Description:

Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.

Treatment:

Device: Somofilcon A contact lenses

Device: Verofilcon A contact lenses