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

Alcon

Status: Completed

Conditions: Refractive Error; Presbyopia

Treatments: Device: Nelfilcon A single vision contact lenses (DACP); Device: Nelfilcon A MF contact lenses (DACP MF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02235831

CLT330-P001

Details and patient eligibility

About

The purpose of this study is to evaluate the visual performance of DAILIES® Aqua Comfort Plus® (DACP) MF contact lens using new objective measurements.

Full description

In this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3 products in randomized order and used 1 product at a time for a duration of 5±1 days before switching to the next assigned product.

Enrollment: 24 patients

Sex: All

Ages: 41 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of soft contact lens wear (hydrogel or silicone hydrogel) in both eyes during the past 3 months and able to wear lenses at least 8 hours a day, 5 days a week
• Spectacle add between +1.50 and +2.50 diopters (D) (inclusive)
• Requiring lenses within the power range of both study contact lenses to be fitted
• Cylinder, if present, less or equal to 0.50D in both eyes at Visit 1
• Vision correctable to 20/30 (0.2 logMAR) or better in each eye at distance
• Acceptable fit with both study contact lenses
• Willing to wear lenses every day or at least for a minimum of 5 days per week 6 hours per day, every day if possible
• Other protocol-defined inclusion criteria may apply

Exclusion criteria

• Current multifocal contact lens wearer
• Current monovision wearer or failed attempt with monovision
• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
• Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator
• Eye injury or surgery within 12 weeks immediately prior to enrollment in this trial
• Any moderate or severe ocular condition observed during the slitlamp examination at the enrollment visit
• History of herpetic keratitis, ocular surgery or irregular cornea
• Prior refractive surgery (e.g. LASIK, PRK, etc)
• Monocular (only 1 eye with functional vision) or fit with only 1 lens
• Habitually uncorrected anisometropia >2.00D
• Clinically significant anisocoria
• Participation in any clinical trial within 30 days of the enrollment visit
• Other protocol-defined exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 3 patient groups

DACP MF

Experimental group

Description:

DACP MF worn first, followed by DACP and DACP MF (Low Add) as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF will be worn bilaterally (in both eyes).

Treatment:

Device: Nelfilcon A single vision contact lenses (DACP)

Device: Nelfilcon A MF contact lenses (DACP MF)

DACP

Active Comparator group

Description:

DACP worn first, followed by DACP MF and DACP MF (Low Add), as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP worn as monovision (distance correction in one eye and near correction in the other eye).

Treatment:

Device: Nelfilcon A single vision contact lenses (DACP)

Device: Nelfilcon A MF contact lenses (DACP MF)

DACP MF (Low Add)

Active Comparator group

Description:

DACP MF (Low Add) worn first, followed by DACP and DACP MF, as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF (Low Add) worn bilaterally (in both eyes).

Treatment:

Device: Nelfilcon A single vision contact lenses (DACP)

Device: Nelfilcon A MF contact lenses (DACP MF)