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

Comparative Assessment of Visual Performance Between DAILIES® AquaComfort Plus® (DACP) Multifocal (MF) and PROCLEAR 1 Day Multifocal (PROCLEAR 1D MF)

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: DACP MF; Device: PROCLEAR 1D MF

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DACP MF, then PROCLEAR 1D MF; 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.	Device: DACP MF; Nelfilcon A multifocal contact lenses; Other Names: DAILIES® AquaComfort Plus® Multifocal (DACP MF); Nelfilcon A; Device: PROCLEAR 1D MF; Omafilcon A multifocal contact lenses; Other Names: PROCLEAR® 1 DAY MULTIFOCAL (PROCLEAR 1D MF); Omafilcon A
Other: PROCLEAR 1D MF, then DACP MF; 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.	Device: DACP MF; Nelfilcon A multifocal contact lenses; Other Names: DAILIES® AquaComfort Plus® Multifocal (DACP MF); Nelfilcon A; Device: PROCLEAR 1D MF; Omafilcon A multifocal contact lenses; Other Names: PROCLEAR® 1 DAY MULTIFOCAL (PROCLEAR 1D MF); Omafilcon A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear	Stereoacuity (SA) is the ability to detect differences in distance (depth perception). Near SA was measured at a distance of 40 cm using the Howard-Dolman system. A lower SA value indicates better depth perception.	Day 5, each product

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear	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. Trial 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.	Day 5, each product

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Manager, Alcon, Spain

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: March 26, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Estimate): August 18, 2016
• Last Update Submitted That Met QC Criteria: July 10, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Visual Performance
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: CLW681-P001