DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02235831
• Collaborator: (none)
• Enrollment: 24
• Arms: 3
• Duration (Days): 30

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the visual performance of DAILIES® Aqua Comfort Plus® (DACP) MF contact lens using new objective measurements.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia; Refractive Error	Device: Nelfilcon A MF contact lenses (DACP MF); Device: Nelfilcon A single vision contact lenses (DACP)	N/A

Detailed Description

In this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3 products in randomized order and used 1 product at a time for a duration of 5±1 days before switching to the next assigned product.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: DAILIES® AquaComfort Plus® MF - Comparative Assessment of Visual Performance Using Objective Measurements
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DACP MF DACP MF worn first, followed by DACP and DACP MF (Low Add) as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF will be worn bilaterally (in both eyes).	Device: Nelfilcon A MF contact lenses (DACP MF); Multifocal contact lenses in Low, Medium, High Add; Device: Nelfilcon A single vision contact lenses (DACP)
Active Comparator: DACP DACP worn first, followed by DACP MF and DACP MF (Low Add), as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP worn as monovision (distance correction in one eye and near correction in the other eye).	Device: Nelfilcon A MF contact lenses (DACP MF); Multifocal contact lenses in Low, Medium, High Add; Device: Nelfilcon A single vision contact lenses (DACP)
Active Comparator: DACP MF (Low Add) DACP MF (Low Add) worn first, followed by DACP and DACP MF, as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF (Low Add) worn bilaterally (in both eyes).	Device: Nelfilcon A MF contact lenses (DACP MF); Multifocal contact lenses in Low, Medium, High Add; Device: Nelfilcon A single vision contact lenses (DACP)

Outcome Measures

Primary Outcome Measures

1. Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance [Day 5, each product]

   Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 41 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• History of soft contact lens wear (hydrogel or silicone hydrogel) in both eyes during the past 3 months and able to wear lenses at least 8 hours a day, 5 days a week

• Spectacle add between +1.50 and +2.50 diopters (D) (inclusive)

• Requiring lenses within the power range of both study contact lenses to be fitted

• Cylinder, if present, less or equal to 0.50D in both eyes at Visit 1

• Vision correctable to 20/30 (0.2 logMAR) or better in each eye at distance

• Acceptable fit with both study contact lenses

• Willing to wear lenses every day or at least for a minimum of 5 days per week 6 hours per day, every day if possible

• Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• Current multifocal contact lens wearer

• Current monovision wearer or failed attempt with monovision

• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear

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

• Eye injury or surgery within 12 weeks immediately prior to enrollment in this trial

• Any moderate or severe ocular condition observed during the slitlamp examination at the enrollment visit

• History of herpetic keratitis, ocular surgery or irregular cornea

• Prior refractive surgery (e.g. LASIK, PRK, etc)

• Monocular (only 1 eye with functional vision) or fit with only 1 lens

• Habitually uncorrected anisometropia >2.00D

• Clinically significant anisocoria

• Participation in any clinical trial within 30 days of the enrollment visit

• Other protocol-defined exclusion criteria may apply

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Clinical Manager, EMEA, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02235831
• Other Study ID Numbers: CLT330-P001
• First Posted: Sep 10, 2014
• Last Update Posted: Jul 11, 2016
• Last Verified: Jun 1, 2016

• Keywords provided by Alcon Research: DACP MF; DAILIES AquaComfort Plus® Multifocal; presbyopia; visual performance
• Additional relevant MeSH terms: Presbyopia; Refractive Errors

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 1 study center located in Spain.
Pre-assignment Detail	Twenty-four subjects were enrolled; all enrolled subjects were also randomized. This reporting group includes all randomized subjects (24).

Arm/Group Title	Seq I	Seq 2	Seq 3	Seq 4	Seq 5	Seq 6
Arm/Group Description	DACP MF lenses worn first, followed by DACP MF (Low Add) lenses next, and DACP (monovision) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.	DACP MF lenses worn first, followed by DACP (monovision) lenses next, and DACP MF (Low Add) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.	DACP MF (Low Add) lenses worn first, followed by DACP MF lenses next, and DACP (monovision) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.	DACP MF (Low Add) lenses worn first, followed by DACP (monovision) lenses next, and DACP MF last. All lenses worn for 5±1 days in a daily wear daily disposable modality.	DACP (monovision) lenses first, followed by DACP MF lenses next, and DACP MF (Low Add) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.	DACP (monovision) lenses first, followed by DACP MF (Low Add) lenses next, and DACP MF lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
Period Title: Period 1, First 5 Days of Wear
STARTED	4	4	4	4	4	4
COMPLETED	4	4	4	4	4	4
NOT COMPLETED	0	0	0	0	0	0
Period Title: Period 1, First 5 Days of Wear
STARTED	4	4	4	4	4	4
COMPLETED	4	4	4	4	4	4
NOT COMPLETED	0	0	0	0	0	0
Period Title: Period 1, First 5 Days of Wear
STARTED	4	4	4	4	4	4
COMPLETED	4	4	4	4	4	4
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	DACP MF, DACP MF (Low Add), and DACP (monovision) lenses worn in 6 different sequences as randomized in a crossover assignment.
Overall Participants	24
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.8 (4.18)
Sex: Female, Male (Count of Participants)
Female	14 58.3%
Male	10 41.7%

Outcome Measures

1. Primary Outcome

Title	Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance
Description	Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.
Time Frame	Day 5, each product

Outcome Measure Data

Analysis Population Description

This analysis population includes all randomized subjects excluding those who met the critical deviation criteria, as specified in the Deviations and Evaluability Plan (DEP).

Arm/Group Title	Monovision	DACP MF
Arm/Group Description	Nelfilcon A contact lenses worn as monovision during Period 1, 2, or 3 for 5±1 days.	Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.
Measure Participants	24	24
Near	0.09	0.18
Intermediate	0.24	0.36

Adverse Events

Time Frame	Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 19 days). This analysis group includes all subjects exposed to any investigational product evaluated in this study, based on treatment-specific exposure.
Adverse Event Reporting Description	An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were reported by the subject or observed by the investigator.
Arm/Group Title	Monovision		DACP MF		DACP MF (Low Add)
Arm/Group Description	Nelfilcon A contact lenses worn as monovision during Period 1, 2, or 3 for 5±1 days.		Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.		Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.
All Cause Mortality
	Monovision		DACP MF		DACP MF (Low Add)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Monovision		DACP MF		DACP MF (Low Add)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Monovision		DACP MF		DACP MF (Low Add)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)		0/24 (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.