Multifocal Lens Design Evaluation

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01997216
• Collaborator: (none)
• Enrollment: 42
• Arms: 2
• Duration (Months): 1

Study Details

Study Description

Brief Summary

The purpose of this study was to compare binocular high contrast, high illumination (HC/HI) visual acuity at near (40 centimeters) of new multifocal contact lenses against AIR OPTIX® AQUA MULTIFOCAL contact lenses when worn for 9 hours.

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

Detailed Description

Each participant was randomized to a specific sequence of lens wear, during which each lens type was worn bilaterally for 9 hours to compare performance characteristics.

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Official Title: Multifocal Lens Design Evaluation (US)
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Delefilcon A MF, then AOAMF Delefilcon A multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.	Device: Delefilcon A multifocal contact lens; Investigational silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines; Device: Lotrafilcon B multifocal contact lens; Commercially marketed silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines; Other Names: AIR OPTIX® AQUA MULTIFOCAL AOAMF
Other: AOAMF, then Delefilcon A MF Lotrafilcon B multifocal contact lenses, followed by delefilcon A multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.	Device: Delefilcon A multifocal contact lens; Investigational silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines; Device: Lotrafilcon B multifocal contact lens; Commercially marketed silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines; Other Names: AIR OPTIX® AQUA MULTIFOCAL AOAMF

Outcome Measures

Primary Outcome Measures

1. Mean Binocular HC/HI Visual Acuity at Near (40 cm) [Up to Hour 9]

   The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal near eyesight. A negative logMAR value denotes better visual acuity.

Secondary Outcome Measures

1. Mean Binocular HC/HI Visual Acuity at Distance [Up to Hour 9]

   The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. A negative logMAR value denotes better visual acuity.

2. Mean Monocular Over-refraction (OR) at Distance [Up to Hour 9]

   OR is the amount of additional correction needed to improve visual acuity (VA). The OR at dispense was conducted with non-study product to determine lens power for the 9-hour wear. Dispensing of the study product (Pair 1 and Pair 2) was dependent upon lens power as determined by OR and resultant product availability. The OR at 9 hours was conducted with study product. All OR data is reported regardless whether study product was dispensed. Each eye 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:

• Sign written Informed Consent document.

• Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses.

• Be presbyopic with a spectacle add ≥ 0.50 diopter.

• Currently wearing soft contact lenses at least 5 days a week.

• Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

• Eye injury or surgery within 12 weeks of enrollment in this trial.

• Pre-existing ocular irritation that would preclude contact lens fitting.

• Currently enrolled in any clinical trial.

• Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses (for at least 9 hours) or use of their accessory solutions as determined by the Investigator.

• Any use of medications for which contact lens wear could be contraindicated as determined by the Investigator.

• Binocular visual acuity worse than 20/25.

• Corrected by monovision.

• 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, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01997216
• Other Study ID Numbers: C-12-036
• First Posted: Nov 28, 2013
• Last Update Posted: Feb 4, 2014
• Last Verified: Dec 1, 2013

• Keywords provided by Alcon Research: contact lenses; multifocal
• Additional relevant MeSH terms: Presbyopia; Refractive Errors

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 1 study center located in the United States.
Pre-assignment Detail	Of the 42 participants enrolled, 1 participant was exited as a screen failure and 1 participant was discontinued due to product unavailability prior to study product exposure. This reporting group includes all enrolled participants exposed to study product (40).

Arm/Group Title	Delefilcon A MF, Then AOAMF	AOAMF, Then Delefilcon A MF
Arm/Group Description	Delefilcon A multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.	Lotrafilcon B multifocal contact lenses, followed by delefilcon A multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.
Period Title: First 9 Hours
STARTED	18	21
COMPLETED	18	21
NOT COMPLETED	0	0
Period Title: First 9 Hours
STARTED	19	21
COMPLETED	19	21
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Delefilcon A multifocal contact lenses and lotrafilcon B multifocal contact lenses, worn as randomized for 9 hours each.
Overall Participants	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.1 (6.0)
Sex: Female, Male (Count of Participants)
Female	25 62.5%
Male	15 37.5%

Outcome Measures

1. Primary Outcome

Title	Mean Binocular HC/HI Visual Acuity at Near (40 cm)
Description	The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal near eyesight. A negative logMAR value denotes better visual acuity.
Time Frame	Up to Hour 9

Outcome Measure Data

Analysis Population Description

All enrolled participants exposed to study product. 1 participant was not exposed to Delefilcon A MF due to product unavailability.

Arm/Group Title	Delefilcon A MF	AOAMF
Arm/Group Description	Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours	Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
Measure Participants	39	40
Dispense (Hour 0)	0.08 (0.10)	0.06 (0.09)
Hour 9	0.05 (0.08)	0.05 (0.10)

2. Secondary Outcome

Title	Mean Binocular HC/HI Visual Acuity at Distance
Description	The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. A negative logMAR value denotes better visual acuity.
Time Frame	Up to Hour 9

Outcome Measure Data

Analysis Population Description

All enrolled participants exposed to study product. 1 participant was not exposed to Delefilcon A MF due to product unavailability.

Arm/Group Title	Delefilcon A MF	AOAMF
Arm/Group Description	Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours	Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
Measure Participants	39	40
Dispense (Hour 0)	-0.06 (0.04)	-0.06 (0.04)
Hour 9	-0.05 (0.08)	-0.05 (0.05)

3. Secondary Outcome

Title	Mean Monocular Over-refraction (OR) at Distance
Description	OR is the amount of additional correction needed to improve visual acuity (VA). The OR at dispense was conducted with non-study product to determine lens power for the 9-hour wear. Dispensing of the study product (Pair 1 and Pair 2) was dependent upon lens power as determined by OR and resultant product availability. The OR at 9 hours was conducted with study product. All OR data is reported regardless whether study product was dispensed. Each eye contributed to the mean.
Time Frame	Up to Hour 9

Outcome Measure Data

Analysis Population Description

All enrolled participants exposed to study product. OR data is included for the 1 participant not exposed to Delefilcon A MF due to product unavailability.

Arm/Group Title	Delefilcon A MF	AOAMF
Arm/Group Description	Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours	Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
Measure Participants	40	40
Dispense (Hour 0)	0.08 (0.14)	0.06 (0.13)
Hour 9	0.06 (0.13)	0.03 (0.12)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study (1 month). An Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical sign whether or not related to the investigational medical device.
Adverse Event Reporting Description	This reporting group includes all enrolled participants exposed to study product. Exposure to the study product (Pair 1 and Pair 2) was dependent upon lens power as determined by OR and resultant product availability.
Arm/Group Title	Delefilcon A MF		AOAMF
Arm/Group Description	Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours		Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 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	0/39 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Delefilcon A MF		AOAMF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/40 (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.