Multifocal Visual Performance Study

• Sponsor: Alcon Research (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03757039
• Collaborator: (none)
• Enrollment: 42
• Locations: 2
• Arms: 2
• Actual Duration (Months): 2.6
• Patients Per Site: 21
• Patients Per Site Per Month: 8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Device: Multifocal soft contact lenses; Other: Progressive addition lens spectacles	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: This was a double-masked trial for the contact lens wearers. The PAL wearers were not masked.
• Primary Purpose: Treatment
• Official Title: Multifocal Visual Performance Study - Seamless Transition With Precision Profile MF Lenses
• Actual Study Start Date: Dec 16, 2018
• Actual Primary Completion Date: Mar 6, 2019
• Actual Study Completion Date: Mar 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Multifocal 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.	Device: Multifocal soft contact lenses; Commercially available contact lenses; Other Names: DAILIES TOTAL1® Multifocal contact lenses (DT1 MF) DAILIES® AquaComfort Plus® Multifocal contact lenses (DACP MF) AIR OPTIX® plus HydraGlyde® Multifocal contact lenses (AOHG MF)
Active Comparator: PAL Spectacles 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; Per subject's habitual prescription; Other Names: PAL

Outcome Measures

Primary Outcome Measures

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) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 38 Years to 58 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigative Site	Houston	Texas	United States	77204-2020
2	Alcon Investigative Site	Birmingham		United Kingdom	B4 7ET

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Senior Clinical Manager, CDMA, Alcon Research, LLC

Study Documents (Full-Text)

• Study Protocol - Oct 19, 2018
• Statistical Analysis Plan - Mar 29, 2019

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT03757039
• Other Study ID Numbers: CLT792-P001
• First Posted: Nov 28, 2018
• Last Update Posted: Mar 25, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Alcon Research: contact lenses; multifocal; spectacles; glasses; progressive; vision; eyes
• Additional relevant MeSH terms: Presbyopia

Study Results

Participant Flow

Recruitment Details	Subjects were enrolled at investigative sites located in the United States (1) and United Kingdom (1).
Pre-assignment Detail	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).

Arm/Group Title	Multifocal Contact Lenses	PAL Spectacles Wearers
Arm/Group Description	All subjects randomized to multifocal contact lenses (AOHG MF, DT1 MF, or DACP MF)	All subjects assigned to progressive addition lens (PAL) spectacles
Period Title: Overall Study
STARTED	32	9
AOHG MF	11	0
DT1 MF	11	0
DACP MF	10	0
COMPLETED	32	9
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	AOHG MF	DT1 MF	DACP MF	PALs	Total
Arm/Group Description	All subjects randomized to AOHG MF	All subjects randomized to DT1 MF	All subjects randomized to DACP MF	All subjects assigned to PALs	Total of all reporting groups
Overall Participants	11	11	10	9	41
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.1 (4.1)	52.5 (4.1)	51.9 (4.0)	51.7 (3.6)	52.0 (3.8)
Sex: Female, Male (Count of Participants)
Female	5 45.5%	8 72.7%	6 60%	5 55.6%	24 58.5%
Male	6 54.5%	3 27.3%	4 40%	4 44.4%	17 41.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	1 9.1%	2 18.2%	0 0%	5 55.6%	8 19.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	1 9.1%	1 9.1%	0 0%	0 0%	2 4.9%
White	8 72.7%	8 72.7%	7 70%	3 33.3%	26 63.4%
More than one race	0 0%	0 0%	1 10%	0 0%	1 2.4%
Unknown or Not Reported	1 9.1%	0 0%	2 20%	1 11.1%	4 9.8%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Multifocal Contact Lenses	PAL Spectacles
Arm/Group Description	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.	Progressive addition lens spectacles according to the subject's habitual prescription, with testing up to 3 hours, 1 day only.
Measure Participants	32	9
Mean (Standard Deviation) [seconds]	2.602 (1.136)	2.774 (0.839)

Adverse Events

Time Frame	Adverse events were collected from time of enrollment until study exit, typically up to approximately 14 days.
Adverse Event Reporting Description	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).
Arm/Group Title	AOHG MF		DT1 MF		DACP MF		PALs
Arm/Group Description	All subjects exposed to AOHG MF		All subjects exposed to DT1 MF		All subjects exposed to DACP MF		All subjects exposed to PALs
All Cause Mortality
	AOHG MF		DT1 MF		DACP MF		PALs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)		0/10 (0%)		0/9 (0%)
Serious Adverse Events
	AOHG MF		DT1 MF		DACP MF		PALs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)		0/10 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	AOHG MF		DT1 MF		DACP MF		PALs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)		0/10 (0%)		1/9 (11.1%)
Eye disorders
Blurred Vision	0/11 (0%)		0/11 (0%)		0/10 (0%)		1/9 (11.1%)
Infections and infestations
Sinusitis	0/11 (0%)		0/11 (0%)		0/10 (0%)		1/9 (11.1%)
Investigations
Blood glucose abnormal	0/11 (0%)		0/11 (0%)		0/10 (0%)		1/9 (11.1%)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.