Performance Assessment of a Modified Daily Disposable Contact Lens

Alcon

Status: Completed

Conditions: Myopia; Refractive Errors; Hyperopia

Treatments: Device: Modified delefilcon A contact lenses; Device: Delefilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT03762668

CLP691-C002

Details and patient eligibility

About

The purpose of this study is to compare visual acuity between two daily disposable contact lenses.

Full description

The expected duration of subject participation in the study is approximately 2 weeks, with 3 scheduled visits.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to understand and sign an approved Informed Consent form;
• Current wearer of commercial DAILIES TOTAL1 Contact Lenses in both eyes;
• Other protocol-specified inclusion criteria may apply.

Exclusion criteria

• Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
• Any eye surgery that contraindicates contact lens wear, as determined by the Investigator;
• Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week)
• Monocular (only one eye with functional vision);
• 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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62 participants in 2 patient groups

MDACL, then DACL

Other group

Description:

Modified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.

Treatment:

Device: Delefilcon A contact lenses

Device: Modified delefilcon A contact lenses

DACL, then MDACL

Other group

Description:

DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.

Treatment:

Device: Delefilcon A contact lenses

Device: Modified delefilcon A contact lenses