Multifocal Visual Performance Study

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

TERMINATED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-16

Study Completion Date

2019-03-06

Brief Summary

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

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Presbyopic Wear Experience With Multifocal Lenses Compared to Single Vision Lenses and Reading Glasses

NCT07218731

Presbyopia Correction Presbyopia

RECRUITING NA

Proclear 1-D Multifocal Nondispensing Study

NCT01526902

Presbyopia

COMPLETED NA

Multifocal High ADD Contact Lens Proof of Concept Trial

NCT02117544

Presbyopia

COMPLETED NA

Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers

NCT06053463

Presbyopia

COMPLETED NA

A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)

NCT01166971

Cataract

COMPLETED PHASE4

Detailed Description

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

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.

Conditions

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

Presbyopia

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

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

This was a double-masked trial for the contact lens wearers. The PAL wearers were not masked.

Study Groups

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

Multifocal Contact Lenses

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.

Group Type EXPERIMENTAL

Multifocal soft contact lenses

Intervention Type DEVICE

Commercially available contact lenses

PAL Spectacles

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

Group Type ACTIVE_COMPARATOR

Progressive addition lens spectacles

Intervention Type OTHER

Per subject's habitual prescription

Interventions

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

Multifocal soft contact lenses

Commercially available contact lenses

Intervention Type DEVICE

Progressive addition lens spectacles

Per subject's habitual prescription

Intervention Type OTHER

Other Intervention Names

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

DAILIES TOTAL1® Multifocal contact lenses (DT1 MF) DAILIES® AquaComfort Plus® Multifocal contact lenses (DACP MF) AIR OPTIX® plus HydraGlyde® Multifocal contact lenses (AOHG MF) PAL

Eligibility Criteria

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

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.

Minimum Eligible Age

38 Years

Maximum Eligible Age

58 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No