Assessing Fitting Guides in Alcon Multifocal Contact Lenses

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03118934
• Collaborator: (none)
• Enrollment: 188
• Locations: 20
• Arms: 3
• Actual Duration (Months): 2.4
• Patients Per Site: 9.4
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

The purpose of this study is to compare an alternative fitting guide to a current fitting guide for optimizing contact lens parameters and determining contact lens prescription.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia; Refractive Errors	Device: Lotrafilcon B multifocal contact lenses; Device: Nelfilcon A multifocal contact lenses; Device: Delefilcon A multifocal contact lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 188 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: Subjects are unmasked to the study lenses that are dispensed, but will be masked to the fitting guides used to fit each eye.
• Primary Purpose: Other
• Official Title: Assessing Fitting Guides in Alcon Multifocal Contact Lenses
• Actual Study Start Date: May 17, 2017
• Actual Primary Completion Date: Jul 7, 2017
• Actual Study Completion Date: Jul 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AOA MF Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 10 ± 3 days	Device: Lotrafilcon B multifocal contact lenses; Contact lenses for near, intermediate, and distance correction worn on a daily wear basis and cared for with participant's habitual lens care solution; Other Names: AIR OPTIX AQUA® Multifocal
Experimental: DACP MF Nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days	Device: Nelfilcon A multifocal contact lenses; Contact lenses for near, intermediate, and distance correction worn on a daily disposable basis (removed every night and discarded) with a new pair of study lenses every morning; Other Names: DAILIES® AquaComfort Plus® Multifocal
Experimental: DT1 MF Delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days	Device: Delefilcon A multifocal contact lenses; Contact lenses for near, intermediate, and distance correction worn on a daily disposable basis (removed every night and discarded) with a new pair of study lenses every morning; Other Names: DAILIES TOTAL1® Multifocal

Outcome Measures

Primary Outcome Measures

1. Mean Number of Trial Lenses Needed to Fit Each Eye [VIsit 1/Day 1]

   The Investigator used a multi-focal contact lens fitting guide to determine which study lens to fit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Sign informed consent;

• Normal eyes;

• Current full-time soft contact lens wearer needing presbyopia correction;

• Willing to wear lenses for a minimum of five days per week, six hours per day, and attend all study visits;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator;

• Eye conditions (past or present) as specified in the protocol;

• Currently wearing Alcon multifocal (MF) contact lenses;

• Only one eye with functional vision;

• Contact lens wear in one eye only;

• Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigative Site	Phoenix	Arizona	United States	85032
2	Alcon Investigative Site	San Diego	California	United States	92123
3	Alcon Investigative Site	Pensacola	Florida	United States	32503
4	Alcon Investigative Site	Tallahassee	Florida	United States	32308
5	Alcon Investigative Site	Pittsburg	Kansas	United States	66762
6	Alcon Investigative Site	Shawnee Mission	Kansas	United States	66204
7	Alcon Investigative Site	Ann Arbor	Michigan	United States	48105
8	Alcon Investigative Site	Eden Prairie	Minnesota	United States	55344
9	Alcon Investigative Site	Medina	Minnesota	United States	55340
10	Alcon Investigative Site	Raytown	Missouri	United States	64133
11	Alcon Investigative Site	Powell	Ohio	United States	43065
12	Alcon Investigative Site	Warwick	Rhode Island	United States	02888
13	Alcon Investigative Site	Memphis	Tennessee	United States	38104
14	Alcon Investigative Site	Memphis	Tennessee	United States	38119
15	Alcon Investigative Site	Burnaby	British Columbia	Canada	V5E 1G3
16	Alcon Investigative Site	Toronto	Ontario	Canada	M2N 3A4
17	Alcon Investigative Site	Toronto		Canada	M2J2Z1
18	Alcon Investigative Site	Coventry		United Kingdom	CV49PQ
19	Alcon Investigative Site	Hereford		United Kingdom	HR1 2PR
20	Alcon Investigative Site	Monmouth		United Kingdom	NP25 3PS

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Clinical Trial Manager, Vision Care, Alcon Research

Study Documents (Full-Text)

• Statistical Analysis Plan - Jun 7, 2017
• Study Protocol - Mar 21, 2017

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT03118934
• Other Study ID Numbers: CLK027-P001
• First Posted: Apr 18, 2017
• Last Update Posted: Sep 26, 2018
• Last Verified: Aug 1, 2018

• 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; presbyopia; multifocal
• Additional relevant MeSH terms: Presbyopia; Refractive Errors

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 20 investigational sites located in the United States (14), United Kingdom (3), and Canada (3).
Pre-assignment Detail	Of the 188 enrolled subjects, 6 were exited prior to trial fit. This reporting group includes all subjects randomized and trial fit, as randomized (182). Safety Analysis Set is reported as exposed.

Arm/Group Title	AOA MF - Alternative	DACP MF - Alternative	DT1 MF - Alternative	AOA MF - Current	DACP MF - Current	DT1 MF - Current
Arm/Group Description	Bilaterally (in both eyes) fitted using alternative fitting guide; lotrafilcon B multifocal contact lenses worn bilaterally for 10 ± 3 days	Bilaterally fitted using alternative fitting guide; nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days	Bilaterally fitted using alternative fitting guide; delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days	Bilaterally fitted using current fitting guide; lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 10 ± 3 days	Bilaterally fitted using current fitting guide; nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days	Bilaterally fitted using current fitting guide; delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days
Period Title: Overall Study
STARTED	34	31	34	29	29	25
Safety Analysis Set	34	29	34	29	26	25
COMPLETED	34	30	33	28	27	23
NOT COMPLETED	0	1	1	1	2	2

Baseline Characteristics

Arm/Group Title	AOA MF	DACP MF	DT1 MF	Total
Arm/Group Description	Lotrafilcon B multifocal contact lenses worn bilaterally for 10 ± 3 days	Nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days	Delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days	Total of all reporting groups
Overall Participants	63	55	59	177
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.6 (6.9)	50.1 (6.7)	50.1 (6.7)	50.3 (6.7)
Sex: Female, Male (Count of Participants)
Female	51 81%	46 83.6%	52 88.1%	149 84.2%
Male	12 19%	9 16.4%	7 11.9%	28 15.8%
Race/Ethnicity, Customized (Count of Participants)
White	55 87.3%	48 87.3%	51 86.4%	154 87%
Black or African American	2 3.2%	4 7.3%	0 0%	6 3.4%
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	5 7.9%	2 3.6%	6 10.2%	13 7.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Other	1 1.6%	1 1.8%	2 3.4%	4 2.3%

Outcome Measures

1. Primary Outcome

Title	Mean Number of Trial Lenses Needed to Fit Each Eye
Description	The Investigator used a multi-focal contact lens fitting guide to determine which study lens to fit
Time Frame	VIsit 1/Day 1

Outcome Measure Data

Analysis Population Description

This analysis population includes all subjects randomized or assigned to study lenses as applicable, and exposed to study lenses including trial fit at Visit 1 (Full Analysis Set).

Arm/Group Title	Alternative	Current
Arm/Group Description	Bilaterally fitted with trial lenses using the alternative fitting guide	Bilaterally fitted with trial lenses using the current fitting guide
Measure Participants	99	83
Measure Eyes	198	166
Mean (Standard Deviation) [lenses]	1.2 (0.5)	1.4 (0.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alternative, Current
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The pre-specified non-inferiority margin is 0.5. With a sample size of 80/group, there was approximately 83% power to reject the null hypothesis of inferiority in fit with assumed standard deviation of 0.6 and expected difference of 0.25 (one-sided alpha=0.05).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LSM Difference
	Estimated Value	-0.2
	Confidence Interval	(1-Sided) 95%; to -0.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.06
	Estimation Comments

Adverse Events

Time Frame	Screening/Fitting through study completion, a maximum of 33 days.
Adverse Event Reporting Description	Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set, as exposed, which is different than "as randomized" due to subjects not following the assigned randomization. "At risk" population for ocular AEs is reported in units of eyes.
Arm/Group Title	AOA MF Ocular		AOA MF Nonocular		DACP MF Ocular		DACP MF Nonocular		DT1 MF Ocular		DT1 MF Nonocular
Arm/Group Description	Eyes exposed to AIR OPTIX AQUA® Multifocal (AOA MF) contact lenses		Subjects exposed to AOA MF contact lenses		Eyes exposed to DAILIES® AquaComfort Plus® Multifocal (DACP MF) contact lenses		Subjects exposed to DACP MF contact lenses		Eyes exposed to DAILIES TOTAL1® Multifocal (DT1 MF) contact lenses		Subjects exposed to DT1 MF contact lenses
All Cause Mortality
	AOA MF Ocular		AOA MF Nonocular		DACP MF Ocular		DACP MF Nonocular		DT1 MF Ocular		DT1 MF Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/126 (0%)		0/63 (0%)		0/110 (0%)		0/55 (0%)		0/118 (0%)		0/59 (0%)
Serious Adverse Events
	AOA MF Ocular		AOA MF Nonocular		DACP MF Ocular		DACP MF Nonocular		DT1 MF Ocular		DT1 MF Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/126 (0%)		0/63 (0%)		0/110 (0%)		0/55 (0%)		0/118 (0%)		0/59 (0%)
Other (Not Including Serious) Adverse Events
	AOA MF Ocular		AOA MF Nonocular		DACP MF Ocular		DACP MF Nonocular		DT1 MF Ocular		DT1 MF Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/126 (0%)		0/63 (0%)		0/110 (0%)		0/55 (0%)		0/118 (0%)		0/59 (0%)

Limitations/Caveats

[Not Specified]

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.