Trial Outcomes & Findings for Multifocal Visual Performance Study (NCT NCT03757039)
NCT ID: NCT03757039
Last Updated: 2020-03-25
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
Day 1, after up to 3 hours of wear
Results posted on
2020-03-25
Participant Flow
Subjects were enrolled at investigative sites located in the United States (1) and United Kingdom (1).
Of the 42 enrolled, 1 subject was exited from the study as a screen failure prior to randomization. This reporting group includes all randomized/assigned subjects (41).
Participant milestones
| Measure |
Multifocal Contact Lenses
All subjects randomized to multifocal contact lenses (AOHG MF, DT1 MF, or DACP MF)
|
PAL Spectacles Wearers
All subjects assigned to progressive addition lens (PAL) spectacles
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
9
|
|
Overall Study
AOHG MF
|
11
|
0
|
|
Overall Study
DT1 MF
|
11
|
0
|
|
Overall Study
DACP MF
|
10
|
0
|
|
Overall Study
COMPLETED
|
32
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multifocal Visual Performance Study
Baseline characteristics by cohort
| Measure |
AOHG MF
n=11 Participants
All subjects randomized to AOHG MF
|
DT1 MF
n=11 Participants
All subjects randomized to DT1 MF
|
DACP MF
n=10 Participants
All subjects randomized to DACP MF
|
PALs
n=9 Participants
All subjects assigned to PALs
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 4.1 • n=93 Participants
|
52.5 years
STANDARD_DEVIATION 4.1 • n=4 Participants
|
51.9 years
STANDARD_DEVIATION 4.0 • n=27 Participants
|
51.7 years
STANDARD_DEVIATION 3.6 • n=483 Participants
|
52.0 years
STANDARD_DEVIATION 3.8 • n=36 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
26 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Day 1, after up to 3 hours of wearPopulation: This analysis population includes all subjects assigned to PALs or randomized to the contact lens group who were exposed to any study product evaluated in this study, except for the lenses used for optimization and fitting (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.
Outcome measures
| Measure |
Multifocal Contact Lenses
n=32 Participants
Multifocal soft contact lenses (AOHG MF, DACP MF, DT1 MF combined) 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
n=9 Participants
Progressive addition lens spectacles according to the subject's habitual prescription, with testing up to 3 hours, 1 day only.
|
|---|---|---|
|
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)
|
2.602 seconds
Standard Deviation 1.136
|
2.774 seconds
Standard Deviation 0.839
|
Adverse Events
AOHG MF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DT1 MF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DACP MF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PALs
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AOHG MF
n=11 participants at risk
All subjects exposed to AOHG MF
|
DT1 MF
n=11 participants at risk
All subjects exposed to DT1 MF
|
DACP MF
n=10 participants at risk
All subjects exposed to DACP MF
|
PALs
n=9 participants at risk
All subjects exposed to PALs
|
|---|---|---|---|---|
|
Eye disorders
Blurred Vision
|
0.00%
0/11 • Adverse events were collected from time of enrollment until study exit, typically up to approximately 14 days.
This analysis population includes all subjects exposed to any study product evaluated in this study, except for the lenses used at Visit 2 for the purpose of parameter optimization and fitting, as they are not intended for the assessment of safety (Safety Analysis Set).
|
0.00%
0/11 • Adverse events were collected from time of enrollment until study exit, typically up to approximately 14 days.
This analysis population includes all subjects exposed to any study product evaluated in this study, except for the lenses used at Visit 2 for the purpose of parameter optimization and fitting, as they are not intended for the assessment of safety (Safety Analysis Set).
|
0.00%
0/10 • Adverse events were collected from time of enrollment until study exit, typically up to approximately 14 days.
This analysis population includes all subjects exposed to any study product evaluated in this study, except for the lenses used at Visit 2 for the purpose of parameter optimization and fitting, as they are not intended for the assessment of safety (Safety Analysis Set).
|
11.1%
1/9 • Adverse events were collected from time of enrollment until study exit, typically up to approximately 14 days.
This analysis population includes all subjects exposed to any study product evaluated in this study, except for the lenses used at Visit 2 for the purpose of parameter optimization and fitting, as they are not intended for the assessment of safety (Safety Analysis Set).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/11 • Adverse events were collected from time of enrollment until study exit, typically up to approximately 14 days.
This analysis population includes all subjects exposed to any study product evaluated in this study, except for the lenses used at Visit 2 for the purpose of parameter optimization and fitting, as they are not intended for the assessment of safety (Safety Analysis Set).
|
0.00%
0/11 • Adverse events were collected from time of enrollment until study exit, typically up to approximately 14 days.
This analysis population includes all subjects exposed to any study product evaluated in this study, except for the lenses used at Visit 2 for the purpose of parameter optimization and fitting, as they are not intended for the assessment of safety (Safety Analysis Set).
|
0.00%
0/10 • Adverse events were collected from time of enrollment until study exit, typically up to approximately 14 days.
This analysis population includes all subjects exposed to any study product evaluated in this study, except for the lenses used at Visit 2 for the purpose of parameter optimization and fitting, as they are not intended for the assessment of safety (Safety Analysis Set).
|
11.1%
1/9 • Adverse events were collected from time of enrollment until study exit, typically up to approximately 14 days.
This analysis population includes all subjects exposed to any study product evaluated in this study, except for the lenses used at Visit 2 for the purpose of parameter optimization and fitting, as they are not intended for the assessment of safety (Safety Analysis Set).
|
|
Investigations
Blood glucose abnormal
|
0.00%
0/11 • Adverse events were collected from time of enrollment until study exit, typically up to approximately 14 days.
This analysis population includes all subjects exposed to any study product evaluated in this study, except for the lenses used at Visit 2 for the purpose of parameter optimization and fitting, as they are not intended for the assessment of safety (Safety Analysis Set).
|
0.00%
0/11 • Adverse events were collected from time of enrollment until study exit, typically up to approximately 14 days.
This analysis population includes all subjects exposed to any study product evaluated in this study, except for the lenses used at Visit 2 for the purpose of parameter optimization and fitting, as they are not intended for the assessment of safety (Safety Analysis Set).
|
0.00%
0/10 • Adverse events were collected from time of enrollment until study exit, typically up to approximately 14 days.
This analysis population includes all subjects exposed to any study product evaluated in this study, except for the lenses used at Visit 2 for the purpose of parameter optimization and fitting, as they are not intended for the assessment of safety (Safety Analysis Set).
|
11.1%
1/9 • Adverse events were collected from time of enrollment until study exit, typically up to approximately 14 days.
This analysis population includes all subjects exposed to any study product evaluated in this study, except for the lenses used at Visit 2 for the purpose of parameter optimization and fitting, as they are not intended for the assessment of safety (Safety Analysis Set).
|
Additional Information
Sr. CDMA Project Lead, Vision Care
Alcon Research, LLC
Phone: 1-888-451-3937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER