NCT03757039

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

December 16, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 25, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

November 27, 2018

Results QC Date

March 10, 2020

Last Update Submit

March 10, 2020

Conditions

Presbyopia

Keywords

contact lensesmultifocalspectaclesglassesprogressivevisioneyes

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Multifocal Contact Lenses

EXPERIMENTAL

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

PAL Spectacles

ACTIVE COMPARATOR

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

Interventions

Multifocal soft contact lensesDEVICE

Commercially available contact lenses

Also known as: DAILIES TOTAL1® Multifocal contact lenses (DT1 MF), DAILIES® AquaComfort Plus® Multifocal contact lenses (DACP MF), AIR OPTIX® plus HydraGlyde® Multifocal contact lenses (AOHG MF)
Multifocal Contact Lenses
Progressive addition lens spectaclesOTHER

Per subject's habitual prescription

Also known as: PAL
PAL Spectacles

Eligibility Criteria

Age38 Years - 58 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alcon Investigative Site

Houston, Texas, 77204-2020, United States

Location

Alcon Investigative Site

Birmingham, B4 7ET, United Kingdom

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Limitations and Caveats

Due to inconsistent measurement of the primary endpoint in this study, interpretation of the average transition times was compromised.

Results Point of Contact

Title
Sr. CDMA Project Lead, Vision Care
Organization
Alcon Research, LLC
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Senior Clinical Manager, CDMA

    Alcon Research, LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
This was a double-masked trial for the contact lens wearers. The PAL wearers were not masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2018

First Posted

November 28, 2018

Study Start

December 16, 2018

Primary Completion

March 6, 2019

Study Completion

March 6, 2019

Last Updated

March 25, 2020

Results First Posted

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)US(1)