Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessing Fitting Guides in Alcon Multifocal Contact Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118934
Recruitment Status : Completed
First Posted : April 18, 2017
Results First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Presbyopia Refractive Errors Device: Lotrafilcon B multifocal contact lenses Device: Nelfilcon A multifocal contact lenses Device: Delefilcon A multifocal contact lenses Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Subjects are unmasked to the study lenses that are dispensed, but will be masked to the fitting guides used to fit each eye.
Primary Purpose: Other
Official Title: Assessing Fitting Guides in Alcon Multifocal Contact Lenses
Actual Study Start Date : May 17, 2017
Actual Primary Completion Date : July 7, 2017
Actual Study Completion Date : July 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear Seizures

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: 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 Name: DAILIES TOTAL1® Multifocal


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118934


Locations
Layout table for location information
United States, Arizona
Alcon Investigative Site
Phoenix, Arizona, United States, 85032
United States, California
Alcon Investigative Site
San Diego, California, United States, 92123
United States, Florida
Alcon Investigative Site
Pensacola, Florida, United States, 32503
Alcon Investigative Site
Tallahassee, Florida, United States, 32308
United States, Kansas
Alcon Investigative Site
Pittsburg, Kansas, United States, 66762
Alcon Investigative Site
Shawnee Mission, Kansas, United States, 66204
United States, Michigan
Alcon Investigative Site
Ann Arbor, Michigan, United States, 48105
United States, Minnesota
Alcon Investigative Site
Eden Prairie, Minnesota, United States, 55344
Alcon Investigative Site
Medina, Minnesota, United States, 55340
United States, Missouri
Alcon Investigative Site
Raytown, Missouri, United States, 64133
United States, Ohio
Alcon Investigative Site
Powell, Ohio, United States, 43065
United States, Rhode Island
Alcon Investigative Site
Warwick, Rhode Island, United States, 02888
United States, Tennessee
Alcon Investigative Site
Memphis, Tennessee, United States, 38104
Alcon Investigative Site
Memphis, Tennessee, United States, 38119
Canada, British Columbia
Alcon Investigative Site
Burnaby, British Columbia, Canada, V5E 1G3
Canada, Ontario
Alcon Investigative Site
Toronto, Ontario, Canada, M2N 3A4
Canada
Alcon Investigative Site
Toronto, Canada, M2J2Z1
United Kingdom
Alcon Investigative Site
Coventry, United Kingdom, CV49PQ
Alcon Investigative Site
Hereford, United Kingdom, HR1 2PR
Alcon Investigative Site
Monmouth, United Kingdom, NP25 3PS
Sponsors and Collaborators
Alcon Research
Investigators
Layout table for investigator information
Study Director: Clinical Trial Manager, Vision Care Alcon Research
  Study Documents (Full-Text)

Documents provided by Alcon Research:
Statistical Analysis Plan  [PDF] June 7, 2017
Study Protocol  [PDF] March 21, 2017

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Results from the Novartis Clinical Trial Results Website  This link exits the ClinicalTrials.gov site

Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03118934     History of Changes
Other Study ID Numbers: CLK027-P001
First Posted: April 18, 2017    Key Record Dates
Results First Posted: September 26, 2018
Last Update Posted: September 26, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Alcon Research:
contact lenses
presbyopia
multifocal
Additional relevant MeSH terms:
Layout table for MeSH terms
Presbyopia
Refractive Errors
Eye Diseases