Assessing Fitting Guides in Alcon Multifocal Contact Lenses

NCT ID: NCT03118934

Last Updated: 2018-09-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-17

Study Completion Date

2017-07-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Presbyopia Refractive Errors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Subjects are unmasked to the study lenses that are dispensed, but will be masked to the fitting guides used to fit each eye.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AOA MF

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

Group Type EXPERIMENTAL

Lotrafilcon B multifocal contact lenses

Intervention Type DEVICE

Contact lenses for near, intermediate, and distance correction worn on a daily wear basis and cared for with participant's habitual lens care solution

DACP MF

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

Group Type EXPERIMENTAL

Nelfilcon A multifocal contact lenses

Intervention Type DEVICE

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

DT1 MF

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

Group Type EXPERIMENTAL

Delefilcon A multifocal contact lenses

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AIR OPTIX AQUA® Multifocal DAILIES® AquaComfort Plus® Multifocal DAILIES TOTAL1® Multifocal

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;

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;
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trial Manager, Vision Care

Role: STUDY_DIRECTOR

Alcon Research

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alcon Investigative Site

Phoenix, Arizona, United States

Site Status

Alcon Investigative Site

San Diego, California, United States

Site Status

Alcon Investigative Site

Pensacola, Florida, United States

Site Status

Alcon Investigative Site

Tallahassee, Florida, United States

Site Status

Alcon Investigative Site

Pittsburg, Kansas, United States

Site Status

Alcon Investigative Site

Shawnee Mission, Kansas, United States

Site Status

Alcon Investigative Site

Ann Arbor, Michigan, United States

Site Status

Alcon Investigative Site

Eden Prairie, Minnesota, United States

Site Status

Alcon Investigative Site

Medina, Minnesota, United States

Site Status

Alcon Investigative Site

Raytown, Missouri, United States

Site Status

Alcon Investigative Site

Powell, Ohio, United States

Site Status

Alcon Investigative Site

Warwick, Rhode Island, United States

Site Status

Alcon Investigative Site

Memphis, Tennessee, United States

Site Status

Alcon Investigative Site

Memphis, Tennessee, United States

Site Status

Alcon Investigative Site

Burnaby, British Columbia, Canada

Site Status

Alcon Investigative Site

Toronto, Ontario, Canada

Site Status

Alcon Investigative Site

Toronto, , Canada

Site Status

Alcon Investigative Site

Coventry, , United Kingdom

Site Status

Alcon Investigative Site

Hereford, , United Kingdom

Site Status

Alcon Investigative Site

Monmouth, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada United Kingdom

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLK027-P001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.