Assessing Fitting Guides in Alcon Multifocal Contact Lenses
1 other identifier
interventional
188
3 countries
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Shorter than P25 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2017
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedStudy Start
First participant enrolled
May 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2017
CompletedResults Posted
Study results publicly available
September 26, 2018
CompletedSeptember 26, 2018
August 1, 2018
2 months
April 11, 2017
July 3, 2018
August 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
AOA MF
EXPERIMENTALLotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 10 ± 3 days
DACP MF
EXPERIMENTALNelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days
DT1 MF
EXPERIMENTALDelefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days
Interventions
Contact lenses for near, intermediate, and distance correction worn on a daily wear basis and cared for with participant's habitual lens care solution
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
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
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (20)
Alcon Investigative Site
Phoenix, Arizona, 85032, United States
Alcon Investigative Site
San Diego, California, 92123, United States
Alcon Investigative Site
Pensacola, Florida, 32503, United States
Alcon Investigative Site
Tallahassee, Florida, 32308, United States
Alcon Investigative Site
Pittsburg, Kansas, 66762, United States
Alcon Investigative Site
Shawnee Mission, Kansas, 66204, United States
Alcon Investigative Site
Ann Arbor, Michigan, 48105, United States
Alcon Investigative Site
Eden Prairie, Minnesota, 55344, United States
Alcon Investigative Site
Medina, Minnesota, 55340, United States
Alcon Investigative Site
Raytown, Missouri, 64133, United States
Alcon Investigative Site
Powell, Ohio, 43065, United States
Alcon Investigative Site
Warwick, Rhode Island, 02888, United States
Alcon Investigative Site
Memphis, Tennessee, 38104, United States
Alcon Investigative Site
Memphis, Tennessee, 38119, United States
Alcon Investigative Site
Burnaby, British Columbia, V5E 1G3, Canada
Alcon Investigative Site
Toronto, Ontario, M2N 3A4, Canada
Alcon Investigative Site
Toronto, M2J2Z1, Canada
Alcon Investigative Site
Coventry, CV49PQ, United Kingdom
Alcon Investigative Site
Hereford, HR1 2PR, United Kingdom
Alcon Investigative Site
Monmouth, NP25 3PS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head, CDMA Vision Care Franchise
- Organization
- Alcon, A Novartis Division
Study Officials
- STUDY DIRECTOR
Clinical Trial Manager, Vision Care
Alcon Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Subjects are unmasked to the study lenses that are dispensed, but will be masked to the fitting guides used to fit each eye.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2017
First Posted
April 18, 2017
Study Start
May 17, 2017
Primary Completion
July 7, 2017
Study Completion
July 28, 2017
Last Updated
September 26, 2018
Results First Posted
September 26, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share