Clinical trial NCT03118934: Assessing Fitting Guides in Alcon Multifocal Contact Lenses
Official title: Assessing Fitting Guides in Alcon Multifocal Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Refractive Errors
Keywords: contact lenses
presbyopia
multifocal
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2017-04-18
Enrollment: 188
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Mean Number of Trial Lenses Needed to Fit Each Eye
timeFrame: VIsit 1/Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Alcon Investigative Site
state: Arizona
city: San Diego
country: United States
facility: Alcon Investigative Site
state: California
city: Pensacola
country: United States
facility: Alcon Investigative Site
state: Florida
city: Tallahassee
country: United States
facility: Alcon Investigative Site
state: Florida
city: Pittsburg
country: United States
facility: Alcon Investigative Site
state: Kansas
city: Shawnee Mission
country: United States
facility: Alcon Investigative Site
state: Kansas
city: Ann Arbor
country: United States
facility: Alcon Investigative Site
state: Michigan
city: Eden Prairie
country: United States
facility: Alcon Investigative Site
state: Minnesota
city: Medina
country: United States
facility: Alcon Investigative Site
state: Minnesota
city: Raytown
country: United States
facility: Alcon Investigative Site
state: Missouri
city: Powell
country: United States
facility: Alcon Investigative Site
state: Ohio
city: Warwick
country: United States
facility: Alcon Investigative Site
state: Rhode Island
city: Memphis
country: United States
facility: Alcon Investigative Site
state: Tennessee
city: Memphis
country: United States
facility: Alcon Investigative Site
state: Tennessee
city: Burnaby
country: Canada
facility: Alcon Investigative Site
state: British Columbia
city: Toronto
country: Canada
facility: Alcon Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Alcon Investigative Site
city: Coventry
country: United Kingdom
facility: Alcon Investigative Site
city: Hereford
country: United Kingdom
facility: Alcon Investigative Site
city: Monmouth
country: United Kingdom
facility: Alcon Investigative Site
Study officials:
affiliation: Alcon Research
name: Clinical Trial Manager, Vision Care
role: STUDY_DIRECTOR
References: