Assessing Fitting Guides in Alcon Multifocal Contact Lenses

The purpose of this study is to compare an alternative fitting guide to a current fitting guide for optimizing contact lens parameters and determining contact lens prescription.

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Presbyopia
• Intervention / Treatment: Device: Lotrafilcon B multifocal contact lenses; Device: Nelfilcon A multifocal contact lenses; Device: Delefilcon A multifocal contact lenses

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Toronto, Canada, M2J2Z1
    • Alcon Investigative Site
  • British Columbia
    • Burnaby, British Columbia, Canada, V5E 1G3
      • Alcon Investigative Site
  • Ontario
    • Toronto, Ontario, Canada, M2N 3A4
      • Alcon Investigative Site
• United Kingdom
  • Coventry, United Kingdom, CV49PQ
    • Alcon Investigative Site
  • Hereford, United Kingdom, HR1 2PR
    • Alcon Investigative Site
  • Monmouth, United Kingdom, NP25 3PS
    • Alcon Investigative Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Alcon Investigative Site
  • California
    • San Diego, California, United States, 92123
      • Alcon Investigative Site
  • Florida
    • Pensacola, Florida, United States, 32503
      • Alcon Investigative Site
    • Tallahassee, Florida, United States, 32308
      • Alcon Investigative Site
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Alcon Investigative Site
    • Shawnee Mission, Kansas, United States, 66204
      • Alcon Investigative Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Alcon Investigative Site
  • Minnesota
    • Eden Prairie, Minnesota, United States, 55344
      • Alcon Investigative Site
    • Medina, Minnesota, United States, 55340
      • Alcon Investigative Site
  • Missouri
    • Raytown, Missouri, United States, 64133
      • Alcon Investigative Site
  • Ohio
    • Powell, Ohio, United States, 43065
      • Alcon Investigative Site
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
      • Alcon Investigative Site
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Alcon Investigative Site
    • Memphis, Tennessee, United States, 38119
      • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Sign informed consent;
• Normal eyes;
• Current full-time soft contact lens wearer needing presbyopia correction;
• Willing to wear lenses for a minimum of five days per week, six hours per day, and attend all study visits;
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator;
• Eye conditions (past or present) as specified in the protocol;
• Currently wearing Alcon multifocal (MF) contact lenses;
• Only one eye with functional vision;
• Contact lens wear in one eye only;
• Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AOA MF; Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 10 ± 3 days	Device: Lotrafilcon B multifocal contact lenses; Contact lenses for near, intermediate, and distance correction worn on a daily wear basis and cared for with participant's habitual lens care solution; Other Names: AIR OPTIX AQUA® Multifocal
Experimental: DACP MF; Nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days	Device: Nelfilcon A multifocal contact lenses; Contact lenses for near, intermediate, and distance correction worn on a daily disposable basis (removed every night and discarded) with a new pair of study lenses every morning; Other Names: DAILIES® AquaComfort Plus® Multifocal
Experimental: DT1 MF; Delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days	Device: Delefilcon A multifocal contact lenses; Contact lenses for near, intermediate, and distance correction worn on a daily disposable basis (removed every night and discarded) with a new pair of study lenses every morning; Other Names: DAILIES TOTAL1® Multifocal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Number of Trial Lenses Needed to Fit Each Eye	The Investigator used a multi-focal contact lens fitting guide to determine which study lens to fit	VIsit 1/Day 1

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Manager, Vision Care, Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Actual): July 7, 2017
• Study Completion (Actual): July 28, 2017

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: presbyopia; contact lenses; multifocal
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: CLK027-P001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes