DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance

Alcon

Status: Completed

Conditions: Presbyopia

Treatments: Device: DACP MF; Device: PROCLEAR 1D MF

Study type: Interventional

Funder types: Industry

Identifiers

NCT02403180

CLW681-P001

Details and patient eligibility

About

The purpose of this study is to evaluate the visual performance of DACP MF and PROCLEAR 1D MF daily disposable contact lenses in an established presbyopic population.

Enrollment: 70 patients

Sex: All

Ages: 41 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must sign an informed consent;
• Adapted soft contact lens wearer;
• Vision correctable to 20/30 [(0.2 logMAR (logarithm of the minimum angle of resolution)] or better in each eye at distance;
• Willing to wear lenses every day or for at least 5 days per week, 6 hours per day;
• Other protocol-specified inclusion criteria may apply.

Exclusion criteria

• Currently wearing multifocal contact lenses;
• Currently wearing monovision;
• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
• Use of systemic or ocular medications which could contraindicate contact lens wear;
• Eye injury or surgery within 12 weeks prior to enrollment;
• Prior refractive surgery;
• Monocular (only 1 eye with functional vision) or fit with only 1 lens;
• 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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70 participants in 2 patient groups

DACP MF, then PROCLEAR 1D MF

Other group

Description:

DACP MF (nelfilcon A) multifocal contact lenses worn in Period 1, followed by PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.

Treatment:

Device: PROCLEAR 1D MF

Device: DACP MF

PROCLEAR 1D MF, then DACP MF

Other group

Description:

PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 1, followed by DACP MF (nelfilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.

Treatment:

Device: PROCLEAR 1D MF

Device: DACP MF