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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

41 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DACP MF

Device

Nelfilcon A multifocal contact lenses

Other names: DAILIES® AquaComfort Plus® Multifocal (DACP MF), Nelfilcon A

PROCLEAR 1D MF

Device

Omafilcon A multifocal contact lenses

Other names: PROCLEAR® 1 DAY MULTIFOCAL (PROCLEAR 1D MF), Omafilcon A

Primary outcomes

Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear

Time frame: Day 5, each product

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.

Secondary outcomes

Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear

Time frame: 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. 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Mar 31, 2015
Registry last updated: Aug 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed