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

NCT ID: NCT02235831

Last Updated: 2016-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2014-10-31

Brief Summary

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

Detailed 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.

Conditions

Presbyopia; Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DACP MF

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).

Group Type: EXPERIMENTAL

Nelfilcon A MF contact lenses (DACP MF)

Intervention Type: DEVICE

Multifocal contact lenses in Low, Medium, High Add

Nelfilcon A single vision contact lenses (DACP)

Intervention Type: DEVICE

DACP

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).

Group Type: ACTIVE_COMPARATOR

Nelfilcon A MF contact lenses (DACP MF)

Intervention Type: DEVICE

Multifocal contact lenses in Low, Medium, High Add

Nelfilcon A single vision contact lenses (DACP)

Intervention Type: DEVICE

DACP MF (Low Add)

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).

Group Type: ACTIVE_COMPARATOR

Nelfilcon A MF contact lenses (DACP MF)

Intervention Type: DEVICE

Multifocal contact lenses in Low, Medium, High Add

Nelfilcon A single vision contact lenses (DACP)

Intervention Type: DEVICE

Interventions

Nelfilcon A MF contact lenses (DACP MF)

Multifocal contact lenses in Low, Medium, High Add

Intervention Type: DEVICE

Nelfilcon A single vision contact lenses (DACP)

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 41 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Manager, EMEA

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

CLT330-P001

Identifier Type: -

Identifier Source: org_study_id