Back to resultsMultifocal Visual Performance Study
Primary Purpose
Presbyopia
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Multifocal soft contact lenses
Progressive addition lens spectacles
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia focused on measuring contact lenses, multifocal, spectacles, glasses, progressive, vision, eyes
Eligibility Criteria
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.
Sites / Locations
- Alcon Investigative Site
- Alcon Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multifocal Contact Lenses
PAL Spectacles
Arm 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.
Progressive addition lens spectacles according to the subject's habitual prescription, with testing up to 3 hours, 1 day only.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03757039
Brief Title
Multifocal Visual Performance Study
Official Title
Multifocal Visual Performance Study - Seamless Transition With Precision Profile MF Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Management Decision
Study Start Date
December 16, 2018 (Actual)
Primary Completion Date
March 6, 2019 (Actual)
Study Completion Date
March 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
contact lenses, multifocal, spectacles, glasses, progressive, vision, eyes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
This was a double-masked trial for the contact lens wearers. The PAL wearers were not masked.
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multifocal Contact Lenses
Arm Type
Experimental
Arm 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.
Arm Title
PAL Spectacles
Arm Type
Active Comparator
Arm Description
Progressive addition lens spectacles according to the subject's habitual prescription, with testing up to 3 hours, 1 day only.
Intervention Type
Device
Intervention Name(s)
Multifocal soft contact lenses
Other Intervention Name(s)
DAILIES TOTAL1® Multifocal contact lenses (DT1 MF), DAILIES® AquaComfort Plus® Multifocal contact lenses (DACP MF), AIR OPTIX® plus HydraGlyde® Multifocal contact lenses (AOHG MF)
Intervention Description
Commercially available contact lenses
Intervention Type
Other
Intervention Name(s)
Progressive addition lens spectacles
Other Intervention Name(s)
PAL
Intervention Description
Per subject's habitual prescription
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Day 1, after up to 3 hours of wear
10. Eligibility
Sex
All
Minimum Age & Unit of Time
38 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Senior Clinical Manager, CDMA
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77204-2020
Country
United States
Facility Name
Alcon Investigative Site
City
Birmingham
ZIP/Postal Code
B4 7ET
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Multifocal Visual Performance Study
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