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

Not Applicable

Completed

• Conditions: Refractive Error; Presbyopia
• Interventions: Device: Nelfilcon A MF contact lenses (DACP MF); Device: Nelfilcon A single vision contact lenses (DACP)

• Registration Number: NCT02235831
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-08
• Study First Submitted QC: 2014-09-09
• Study First Posted: 2014-09-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2015-10-30
• Results First Submitted QC: 2015-12-14
• Results First Posted: 2016-01-18
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-08
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DACP MF	Nelfilcon A MF contact lenses (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).
DACP	Nelfilcon A MF contact lenses (DACP MF)	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).
DACP MF (Low Add)	Nelfilcon A single vision contact lenses (DACP)	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).
DACP MF	Nelfilcon A single vision contact lenses (DACP)	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).
DACP	Nelfilcon A single vision contact lenses (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).
DACP MF (Low Add)	Nelfilcon A MF contact lenses (DACP MF)	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).

Primary Outcome Measures

Name	Time	Method
Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance	Day 5, each product	Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.