Evaluation of a New Daily Disposable Multifocal Contact Lens Design

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01951573
• Collaborator: (none)
• Enrollment: 36
• Arms: 2
• Duration (Months): 1

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate non-inferiority of a new daily disposable multifocal contact lens in plus powers against the commercially available AIR OPTIX® AQUA MULTIFOCAL (AOAMF) lens in high contrast/high illumination (HC/HI) near visual acuity (VA).

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Delefilcon A Multifocal Plus Power Lens Design Evaluation
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: Delefilcon A MF, then AOAMF Delefilcon A multifocal contact lenses first, followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.	Device: Delefilcon A multifocal contact lenses; Silicone hydrogel multifocal contact lenses for daily wear, daily disposable use; Device: Lotrafilcon B multifocal contact lenses; Silicone hydrogel multifocal contact lenses with a labeled indication for daily wear and extended wear use of up to 6 days with monthly replacement; Other Names: AIR OPTIX® AQUA MULTIFOCAL
Other: AOAMF, then Delefilcon A MF Lotrafilcon B multifocal contact lenses first, followed by delefilcon A multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.	Device: Delefilcon A multifocal contact lenses; Silicone hydrogel multifocal contact lenses for daily wear, daily disposable use; Device: Lotrafilcon B multifocal contact lenses; Silicone hydrogel multifocal contact lenses with a labeled indication for daily wear and extended wear use of up to 6 days with monthly replacement; Other Names: AIR OPTIX® AQUA MULTIFOCAL

Outcome Measures

Primary Outcome Measures

1. High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near [Dispense (Day 1), Hour 9]

   Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.

Secondary Outcome Measures

1. HC/HI Binocular VA at Distance [Dispense (Day 1), Hour 9]

   Distance VA was assessed binocularly (both eyes together) at 6 meters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.

2. Over-refraction (OR) Monocular at Distance [Dispense (Day 1), Hour 9]

   OR (the amount of additional correction needed to improve VA) at distance (equivalent to 6 meters) was assessed monocularly (for each eye separately) in diopters (D). Both eyes contributed to the mean.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects with normal eyes who are not using any ocular medication.

• Must sign the Informed Consent document.

• Habitual lens power within the range available for the study lenses (+1.00 to +3.50 diopters(D)).

• Manifest cylinder less than or equal to 0.75D.

• Best corrected distance VA greater than or equal to 20/25 in each eye.

• Existing soft contact lens (CL) wearers who wear contact lenses in both eyes at least 5 days per week.

• Presbyopic with a spectacle addition (ADD) >0.50D and <2.75D.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any ocular disease, inflammation, or abnormality that contraindicates CL wear.

• Any use of systemic or ocular medications for which CL wear could be contraindicated.

• History of herpetic keratitis.

• History of refractive surgery or irregular cornea.

• A clinically significant dry eye that precludes CL wear.

• Participation of the subject in a clinical study (including CL or CL care product) within the previous 30 days.

• Monocular (only 1 eye with functional vision).

• History of intolerance or hypersensitivity to any component of the test articles.

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Joachim Nick, Dipl. Ing., CIBA VISION GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01951573
• Other Study ID Numbers: C-13-011
• First Posted: Sep 26, 2013
• Last Update Posted: Dec 2, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Alcon Research: contact lenses; multifocal; daily disposable; silicone hydrogel; presbyopia
• Additional relevant MeSH terms: Presbyopia; Refractive Errors; Hyperopia

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 1 study center located in the US.
Pre-assignment Detail	Of the 36 enrolled, 2 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (34).

Arm/Group Title	Delefilcon A MF, Then AOAMF	AOAMF, Then Delefilcon A MF
Arm/Group Description	Each product worn bilaterally (ie, in both eyes), as randomized, for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.	Each product worn bilaterally (ie, in both eyes), as randomized, for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.
Period Title: Period 1, First 9 Hours of Wear
STARTED	17	17
COMPLETED	17	17
NOT COMPLETED	0	0
Period Title: Period 1, First 9 Hours of Wear
STARTED	17	17
COMPLETED	17	16
NOT COMPLETED	0	1
Period Title: Period 1, First 9 Hours of Wear
STARTED	17	16
COMPLETED	17	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Delefilcon A MF and AOAMF contact lenses worn during Period 1 and Period 2 in a crossover assignment.
Overall Participants	34
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.9 (8.2)
Sex: Female, Male (Count of Participants)
Female	30 88.2%
Male	4 11.8%

Outcome Measures

1. Primary Outcome

Title	High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near
Description	Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.
Time Frame	Dispense (Day 1), Hour 9

Outcome Measure Data

Analysis Population Description

This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.

Arm/Group Title	Delefilcon A MF	AOAMF
Arm/Group Description	Contact lenses worn during Period 1 or Period 2 for 9-12 hours	Contact lenses worn during Period 1 or Period 2 for 9-12 hours
Measure Participants	33	34
Dispense	0.10 (0.09)	0.12 (0.06)
Hour 9	0.08 (0.09)	0.09 (0.07)

2. Secondary Outcome

Title	HC/HI Binocular VA at Distance
Description	Distance VA was assessed binocularly (both eyes together) at 6 meters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.
Time Frame	Dispense (Day 1), Hour 9

Outcome Measure Data

Analysis Population Description

This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.

Arm/Group Title	Delefilcon A MF	AOAMF
Arm/Group Description	Contact lenses worn during Period 1 or Period 2 for 9-12 hours	Contact lenses worn during Period 1 or Period 2 for 9-12 hours
Measure Participants	33	34
Dispense	-0.02 (0.06)	-0.03 (0.06)
Hour 9	0.00 (0.07)	-0.01 (0.07)

3. Secondary Outcome

Title	Over-refraction (OR) Monocular at Distance
Description	OR (the amount of additional correction needed to improve VA) at distance (equivalent to 6 meters) was assessed monocularly (for each eye separately) in diopters (D). Both eyes contributed to the mean.
Time Frame	Dispense (Day 1), Hour 9

Outcome Measure Data

Analysis Population Description

This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.

Arm/Group Title	Delefilcon A MF	AOAMF
Arm/Group Description	Contact lenses worn during Period 1 or Period 2 for 9-12 hours	Contact lenses worn during Period 1 or Period 2 for 9-12 hours
Measure Participants	33	34
Measure eyes	66	68
Dispense	0.00 (0.00)	0.00 (0.00)
Hour 9	0.11 (0.16)	0.09 (0.14)

Adverse Events

Time Frame	Adverse events (AEs) were collected from 04 Oct 2013 to 12 Nov 2013. This analysis group includes all subjects/eyes exposed to any Investigational Product (IP) evaluated in this study.
Adverse Event Reporting Description	An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device.
Arm/Group Title	Delefilcon A MF		AOAMF
Arm/Group Description	Contact lenses worn during Period 1 or Period 2 for 9-12 hours		Contact lenses worn during Period 1 or Period 2 for 9-12 hours
All Cause Mortality
	Delefilcon A MF		AOAMF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Delefilcon A MF		AOAMF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/34 (0%)
Other (Not Including Serious) Adverse Events
	Delefilcon A MF		AOAMF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/34 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.