Assessing Fitting Guides in Alcon Multifocal Contact Lenses

Not Applicable

Completed

• Conditions: Refractive Errors; Presbyopia
• Interventions: Device: Lotrafilcon B multifocal contact lenses; Device: Delefilcon A multifocal contact lenses; Device: Nelfilcon A multifocal contact lenses

• Registration Number: NCT03118934
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-11
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-18
• Study Start: 2017-05-17
• Primary Completion: 2017-07-07
• Study Completion: 2017-07-28
• Results First Submitted: 2018-07-03
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-28
• Last Update Submitted: 2018-08-28
• Results First Posted: 2018-09-26
• Last Update Posted: 2018-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AOA MF	Lotrafilcon B multifocal contact lenses	Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 10 ± 3 days
DT1 MF	Delefilcon A multifocal contact lenses	Delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days
DACP MF	Nelfilcon A multifocal contact lenses	Nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days

Primary Outcome Measures

Name	Time	Method
Mean Number of Trial Lenses Needed to Fit Each Eye	VIsit 1/Day 1	The Investigator used a multi-focal contact lens fitting guide to determine which study lens to fit

Trial Locations

Locations (1)

Alcon Investigative Site; 🇬🇧 Monmouth, United Kingdom