Multifocal Visual Performance Study

Alcon

Status: Terminated

Conditions: Presbyopia

Treatments: Device: Multifocal soft contact lenses; Other: Progressive addition lens spectacles

Study type: Interventional

Funder types: Industry

Identifiers

NCT03757039

CLT792-P001

Details and patient eligibility

About

The purpose of this trial was to compare the functional visual performance of Precision Profile Multifocal (MF) contact lenses to Progressive Addition Lens (PAL) spectacles in a presbyopic population.

Full description

Habitual contact lens wearers were randomized 1:1:1 to one of three commercially available multifocal contact lenses. Progressive addition lens wearers wore their habitual spectacles. Subjects were expected to attend 1 or 2 office visits. This study was terminated early by Alcon due to slow enrollment and inconsistency in measurement of the primary endpoint.

Enrollment: 42 patients

Sex: All

Ages: 38 to 58 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Normal eyes, other than correction for refractive error;
• Habitual correction of either any multifocal contact lens with a maximum add of +2.00 Diopter (D), or progressive addition lens spectacles with a maximum add of +2.00 D;
• Wears habitual correction at least 5 days per week and at least 6 hours per day.

Exclusion criteria

• Monocular subjects;
• Subjects fit with only one contact lens;
• Known pregnancy or lactating;
• History of or planned refractive surgery or irregular cornea in either eye.

Other protocol-specified inclusion and/or exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Multifocal Contact Lenses

Experimental group

Description:

Multifocal soft contact lenses according to the subject's prescription and fitted using the Alcon multifocal fitting guide. Lenses were worn bilaterally (in both eyes) for up to 3 hours, 1 day only.

Treatment:

Device: Multifocal soft contact lenses

PAL Spectacles

Active Comparator group

Description:

Progressive addition lens spectacles according to the subject's habitual prescription, with testing up to 3 hours, 1 day only.

Treatment:

Other: Progressive addition lens spectacles