Multifocal Visual Performance Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multifocal Visual Performance Study - Seamless Transition With Precision Profile MF Lenses

Conditions
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Presbyopia

Intervention / Treatment
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* Device: Multifocal soft contact lenses
* Other: Progressive addition lens spectacles


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 38 Years
Maximum Age: 58 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multifocal Contact Lenses<br>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. | Device: Multifocal soft contact lenses<br>* Commercially available contact lenses<br>* Other names: AIR OPTIX® plus HydraGlyde® Multifocal contact lenses (AOHG MF);|
| Active Comparator: PAL Spectacles<br>Progressive addition lens spectacles according to the subject's habitual prescription, with testing up to 3 hours, 1 day only. | Other: Progressive addition lens spectacles<br>* Per subject's habitual prescription<br>* Other names: PAL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Transition Time, Calculated From a Maximum of 3 Readings, Recorded in Seconds, During Alternate Viewing From Distance (4 m) to Intermediate (80 cm) and Vice Versa (Full Analysis Set) | The subject was asked to read text at distance (4 meters) or intermediate (80 centimeters), followed immediately by text at the alternate viewing (intermediate or distance). The interval between when the subject stopped reading the first text and started reading the second text is defined as the transition time. Due to inconsistent measurement of the primary endpoint in this study, interpretation of the average transition times was compromised and the planned inferential analysis was not carried out. | Day 1, after up to 3 hours of wear | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contact lenses, multifocal, spectacles, glasses, progressive, vision, eyes