Assessing Fitting Guides in Alcon Multifocal Contact Lenses

Alcon

Status: Completed

Conditions: Refractive Errors; Presbyopia

Treatments: Device: Delefilcon A multifocal contact lenses; Device: Lotrafilcon B multifocal contact lenses; Device: Nelfilcon A multifocal contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT03118934

CLK027-P001

Details and patient eligibility

About

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.

Enrollment: 188 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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188 participants in 3 patient groups

AOA MF

Experimental group

Description:

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

Treatment:

Device: Lotrafilcon B multifocal contact lenses

DACP MF

Experimental group

Description:

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

Treatment:

Device: Nelfilcon A multifocal contact lenses

DT1 MF

Experimental group

Description:

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

Treatment:

Device: Delefilcon A multifocal contact lenses