Assessing Fitting Guides in Alcon Multifocal Contact Lenses

Presbyopia Clinical Trial

Official title:

Assessing Fitting Guides in Alcon Multifocal Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118934
• Other study ID #: CLK027-P001
• Status: Completed
• Phase: N/A
• Start date: May 17, 2017
• Est. completion date: July 28, 2017

Study information

• Verified date: August 2018
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: July 28, 2017
• Est. primary completion date: July 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Presbyopia
• Refractive Errors

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Canada	Alcon Investigative Site	Burnaby	British Columbia
Canada	Alcon Investigative Site	Toronto	Ontario
Canada	Alcon Investigative Site	Toronto
United Kingdom	Alcon Investigative Site	Coventry
United Kingdom	Alcon Investigative Site	Hereford
United Kingdom	Alcon Investigative Site	Monmouth
United States	Alcon Investigative Site	Ann Arbor	Michigan
United States	Alcon Investigative Site	Eden Prairie	Minnesota
United States	Alcon Investigative Site	Medina	Minnesota
United States	Alcon Investigative Site	Memphis	Tennessee
United States	Alcon Investigative Site	Memphis	Tennessee
United States	Alcon Investigative Site	Pensacola	Florida
United States	Alcon Investigative Site	Phoenix	Arizona
United States	Alcon Investigative Site	Pittsburg	Kansas
United States	Alcon Investigative Site	Powell	Ohio
United States	Alcon Investigative Site	Raytown	Missouri
United States	Alcon Investigative Site	San Diego	California
United States	Alcon Investigative Site	Shawnee Mission	Kansas
United States	Alcon Investigative Site	Tallahassee	Florida
United States	Alcon Investigative Site	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Results from the Novartis Clinical Trial Results Website