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Assessing Fitting Guides in Alcon Multifocal Contact Lenses

Primary Purpose

Presbyopia, Refractive Errors

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lotrafilcon B multifocal contact lenses
Nelfilcon A multifocal contact lenses
Delefilcon A multifocal contact lenses
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Presbyopia focused on measuring contact lenses, presbyopia, multifocal

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

AOA MF

DACP MF

DT1 MF

Arm Description

Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 10 ± 3 days

Nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days

Delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 11, 2017
Last Updated
August 28, 2018
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT03118934
Brief Title
Assessing Fitting Guides in Alcon Multifocal Contact Lenses
Official Title
Assessing Fitting Guides in Alcon Multifocal Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 17, 2017 (Actual)
Primary Completion Date
July 7, 2017 (Actual)
Study Completion Date
July 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia, Refractive Errors
Keywords
contact lenses, presbyopia, multifocal

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AOA MF
Arm Type
Experimental
Arm Description
Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 10 ± 3 days
Arm Title
DACP MF
Arm Type
Experimental
Arm Description
Nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days
Arm Title
DT1 MF
Arm Type
Experimental
Arm Description
Delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B multifocal contact lenses
Other Intervention Name(s)
AIR OPTIX AQUA® Multifocal
Intervention Description
Contact lenses for near, intermediate, and distance correction worn on a daily wear basis and cared for with participant's habitual lens care solution
Intervention Type
Device
Intervention Name(s)
Nelfilcon A multifocal contact lenses
Other Intervention Name(s)
DAILIES® AquaComfort Plus® Multifocal
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Delefilcon A multifocal contact lenses
Other Intervention Name(s)
DAILIES TOTAL1® Multifocal
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean Number of Trial Lenses Needed to Fit Each Eye
Description
The Investigator used a multi-focal contact lens fitting guide to determine which study lens to fit
Time Frame
VIsit 1/Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Manager, Vision Care
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Alcon Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Alcon Investigative Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Alcon Investigative Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Alcon Investigative Site
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Alcon Investigative Site
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Alcon Investigative Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Alcon Investigative Site
City
Eden Prairie
State/Province
Minnesota
ZIP/Postal Code
55344
Country
United States
Facility Name
Alcon Investigative Site
City
Medina
State/Province
Minnesota
ZIP/Postal Code
55340
Country
United States
Facility Name
Alcon Investigative Site
City
Raytown
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
Alcon Investigative Site
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States
Facility Name
Alcon Investigative Site
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Facility Name
Alcon Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Alcon Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Alcon Investigative Site
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5E 1G3
Country
Canada
Facility Name
Alcon Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2N 3A4
Country
Canada
Facility Name
Alcon Investigative Site
City
Toronto
ZIP/Postal Code
M2J2Z1
Country
Canada
Facility Name
Alcon Investigative Site
City
Coventry
ZIP/Postal Code
CV49PQ
Country
United Kingdom
Facility Name
Alcon Investigative Site
City
Hereford
ZIP/Postal Code
HR1 2PR
Country
United Kingdom
Facility Name
Alcon Investigative Site
City
Monmouth
ZIP/Postal Code
NP25 3PS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessing Fitting Guides in Alcon Multifocal Contact Lenses

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