Multifocal Visual Performance Study

Not Applicable

Terminated

• Conditions: Presbyopia
• Interventions: Device: Multifocal soft contact lenses; Other: Progressive addition lens spectacles

• Registration Number: NCT03757039
• Lead Sponsor: Alcon Research

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-11-27
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-28
• Study Start: 2018-12-16
• Primary Completion: 2019-03-06
• Study Completion: 2019-03-06
• Status Verified: 2020-03
• Results First Submitted: 2020-03-10
• Results First Submitted QC: 2020-03-10
• Last Update Submitted: 2020-03-10
• Results First Posted: 2020-03-25
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multifocal Contact Lenses	Multifocal soft 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.
PAL Spectacles	Progressive addition lens spectacles	Progressive addition lens spectacles according to the subject's habitual prescription, with testing up to 3 hours, 1 day only.

Primary Outcome Measures

Name	Time	Method
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)	Day 1, after up to 3 hours of wear	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.

Trial Locations

Locations (1)

Alcon Investigative Site; 🇬🇧 Birmingham, United Kingdom