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Completed

NCT Number: NCT02235831

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

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

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Key information

Age range

41 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Nelfilcon A MF contact lenses (DACP MF)

Device

Multifocal contact lenses in Low, Medium, High Add

Nelfilcon A single vision contact lenses (DACP)

Device

Primary outcomes

  1. Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance

    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. 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

DAILIES® AquaComfort Plus® MF - Comparative Assessment of Visual Performance Using Objective Measurements

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 10, 2014
Registry last updated
Jul 11, 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.

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