Tear Film Evaluation of Dailies® AquaComfort Plus® Multifocal and Toric

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02289742
• Collaborator: (none)
• Enrollment: 48
• Arms: 2
• Duration (Months): 3

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the pre lens tear film characteristics of DAILIES® Aqua Comfort Plus® Multifocal (DACP MF) and Toric (DACP Toric) compared to DAILIES® Aqua Comfort Plus® Sphere (DACP) daily disposable contact lenses over 12 hours of lens wear.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error	Device: Nelfilcon A multifocal contact lenses; Device: Nelfilcon A toric contact lenses; Device: Nelfilcon A sphere contact lenses	N/A

Detailed Description

Two population groups (presbyopes and astigmats) will be enrolled in the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Characterization of Pre-Lens Tear Film Stability of Daily Disposable Multifocal and Toric Contact Lenses Using Ring Mire Projection
• Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Arm1: Presbyopes Nelfilcon A contact lenses (multifocal and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.	Device: Nelfilcon A multifocal contact lenses; Other Names: DAILIES® AquaComfort Plus® Multifocal DACP MF ; Device: Nelfilcon A sphere contact lenses; Other Names: DAILIES® AquaComfort Plus® DACP
Other: Arm2: Astigmats Nelfilcon A contact lenses (toric and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.	Device: Nelfilcon A toric contact lenses; Other Names: DAILIES® AquaComfort Plus® Toric DACP Toric ; Device: Nelfilcon A sphere contact lenses; Other Names: DAILIES® AquaComfort Plus® DACP

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear [Hour 12, each product]

   A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.

Secondary Outcome Measures

1. Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear [Hour 8, each product]

   A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Must sign an informed consent document;

• Adapted, current soft contact lens wearer with either:

1. A spectacle add between +0.50 and +2.50 (inclusive) [Presbyopes group]

2. A spherical correction of an astigmatism up to 20% of the amount of the sphere [Astigmats group];

• Contact lens prescription in the power range specified in the protocol;

• Vision correctable to 0.2 logMAR (logarithmic minimal angle for resolution) or better in each eye at distance with pre-study lenses or manifest refraction at Visit 1;

• Willing to wear study lenses up to 12 hours and attend all study visits;

• Can be successfully fitted with study lenses;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

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

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

• Use of artificial tears and rewetting drops during the study;

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

• Any abnormal ocular condition observed during the Visit 1 slit-lamp examination;

• History of herpetic keratitis, ocular surgery, or irregular cornea;

• Pregnant or lactating;

• Unstable tear film with a NIK-BUT value below 8 seconds in either eye without lenses;

• Participation in any clinical study within 30 days of Visit 1;

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Sr. Clinical Manager, Global Med Affairs, Operations, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02289742
• Other Study ID Numbers: M-14-010
• First Posted: Nov 13, 2014
• Last Update Posted: Jul 26, 2016
• Last Verified: Jun 1, 2016

• Keywords provided by Alcon Research: Dailies AquaComfort Plus® Multifocal (DACP MF); Dailies AquaComfort Plus® Toric (DACP Toric); tear film stability; Non-Invasive Keratograph Break-Up Time (NIK-BUT)
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 1 study center located in Germany.
Pre-assignment Detail	Of the 48 enrolled subjects, 3 were discontinued as screen failures prior to randomization. This reporting group includes all randomized subjects (45).

Arm/Group Title	Presbyopes MF/Sphere	Presbyopes Sphere/MF	Astigmats Toric/Sphere	Astigmats Sphere/Toric
Arm/Group Description	Nelfilcon A multifocal contact lenses in Period 1, followed by nelfilcon A sphere contact lenses in Periods 2 and 3. Each product worn bilaterally (in both eyes) for 12 hours.	Nelfilcon A sphere contact lenses in Periods 1 and 3, with nelfilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 12 hours.	Nelfilcon A toric contact lenses in Period 1, followed by nelfilcon A sphere contact lenses in Periods 2 and 3. Each product worn bilaterally (in both eyes) for 12 hours.	Nelfilcon A sphere contact lenses in Periods 1 and 3, with nelfilcon A toric contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 12 hours.
Period Title: First Wear Period
STARTED	11	12	12	10
Treated	11	11	12	9
COMPLETED	11	11	11	9
NOT COMPLETED	0	1	1	1
Period Title: First Wear Period
STARTED	11	11	11	9
COMPLETED	11	11	11	9
NOT COMPLETED	0	0	0	0
Period Title: First Wear Period
STARTED	11	11	11	9
COMPLETED	11	10	11	8
NOT COMPLETED	0	1	0	1

Baseline Characteristics

Arm/Group Title	Presbyopes	Astigmats	Total
Arm/Group Description	Nelfilcon A contact lenses (multifocal and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.	Nelfilcon A contact lenses (toric and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.	Total of all reporting groups
Overall Participants	22	21	43
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.7 (8.1)	25.8 (4.5)	39.0 (14.6)
Sex: Female, Male (Count of Participants)
Female	16 72.7%	16 76.2%	32 74.4%
Male	6 27.3%	5 23.8%	11 25.6%
Region of Enrollment (participants) [Number]
Germany	22 100%	21 100%	43 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear
Description	A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.
Time Frame	Hour 12, each product

Outcome Measure Data

Analysis Population Description

This analysis population includes all randomized and exposed subjects with data at visit.

Arm/Group Title	Presbyopes / Multifocal	Presbyopes / Sphere	Astigmats / Toric	Astigmats / Sphere
Arm/Group Description	Nelfilcon A multifocal contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or 2	Nelfilcon A spherical contact lenses worn balaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3	Nelfilcon A toric contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design)	Nelfilcon A spherical contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
Measure Participants	22	22	21	20
Number [percentage of subjects]	55.8	47.2	46.5	49.5

2. Secondary Outcome

Title	Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear
Description	A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.
Time Frame	Hour 8, each product

Outcome Measure Data

Analysis Population Description

This analysis population includes all randomized and exposed subjects with data at visit.

Arm/Group Title	Presbyopes / Multifocal	Presbyopes / Sphere	Astigmats / Toric	Astigmats / Sphere
Arm/Group Description	Nelfilcon A multifocal contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or 2	Nelfilcon A spherical contact lenses worn balaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3	Nelfilcon A toric contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 ( in a crossover design)	Nelfilcon A spherical contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
Measure Participants	22	22	21	20
Number [percentage of subjects]	60.8	46.3	34.3	33.3

Adverse Events

Time Frame	Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 24 days). Ocular adverse events are presented for both study eye and non-study eye combined. AEs were reported as pre-treatment and treatment-emergent.
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.
Arm/Group Title	Pre-treatment		Presbyopes / Multifocal		Presbyopes / Sphere First Exposure		Presbyopes / Sphere Second Exposure		Astigmats / Toric		Astigmats / Sphere First Exposure		Astigmats / Sphere Second Exposure
Arm/Group Description	All subjects who consented to participate in the study prior to the initiation of study treatment		All subjects exposed to nelfilcon A multifocal contact lenses, worn bilaterally (in both eyes) for 12 hours during Periods 1 or 2 as randomized		All presbyopes exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 as randomized		All presbyopes exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 3		All subjects exposed to nelfilcon A toric contact lenses, worn bilaterally (in both eyes) for 12 hours during Periods 1 or 2 as randomized		All astigmats exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 as randomized		All astigmats exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 3
All Cause Mortality
	Pre-treatment		Presbyopes / Multifocal		Presbyopes / Sphere First Exposure		Presbyopes / Sphere Second Exposure		Astigmats / Toric		Astigmats / Sphere First Exposure		Astigmats / Sphere Second Exposure
	Affected / at Risk (%)	# Events	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	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Pre-treatment		Presbyopes / Multifocal		Presbyopes / Sphere First Exposure		Presbyopes / Sphere Second Exposure		Astigmats / Toric		Astigmats / Sphere First Exposure		Astigmats / Sphere Second Exposure
	Affected / at Risk (%)	# Events	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	0/48 (0%)		0/22 (0%)		0/22 (0%)		0/22 (0%)		0/21 (0%)		0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Pre-treatment		Presbyopes / Multifocal		Presbyopes / Sphere First Exposure		Presbyopes / Sphere Second Exposure		Astigmats / Toric		Astigmats / Sphere First Exposure		Astigmats / Sphere Second Exposure
	Affected / at Risk (%)	# Events	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	0/48 (0%)		0/22 (0%)		0/22 (0%)		0/22 (0%)		0/21 (0%)		0/20 (0%)		0/20 (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.