Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01839318
• Collaborator: (none)
• Enrollment: 30
• Arms: 3
• Duration (Months): 2

Study Details

Study Description

Brief Summary

The purpose of this study was to compare three CE-marked daily disposable contact lenses for tear film stability as measured by pre-lens non-invasive keratograph break up time (PL NIK-BUT). Secondarily, contact lens surface wettability was assessed.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Hyperopia; Refractive Error	Device: Nelfilcon A contact lenses; Device: Omafilcon A contact lenses; Device: Etafilcon A contact lenses	N/A

Detailed Description

Each participant wore 3 brands of contact lenses in a randomized, cross-over fashion, with a washout phase of at least 1 night between brands.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses Using Ring Mire Projection
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DAILIES AquaComfort Plus Nelfilcon A contact lenses worn first, followed by etafilcon A and omafilcon A in randomized order. Each product worn for 1 day, 12 hours.	Device: Nelfilcon A contact lenses; Other Names: DAILIES® AquaComfort Plus®
Active Comparator: 1-DAY ACUVUE MOIST Etafilcon A contact lenses worn first, followed by nelfilcon A and omafilcon A in randomized order. Each product worn for 1 day, 12 hours.	Device: Etafilcon A contact lenses; Other Names: 1-DAY ACUVUE® MOIST®
Active Comparator: Proclear 1 day Omafilcon A contact lenses worn first, followed by etafilcon A and nelfilcon A in randomized order. Each product worn for 1 day, 12 hours.	Device: Omafilcon A contact lenses; Other Names: Proclear® 1 day

Outcome Measures

Primary Outcome Measures

1. Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours [Hour 8]

   The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean.

Secondary Outcome Measures

1. Total Wettability Score [Hour 8]

   The investigator graded lens wettability by corneal region using a scale from 0 (fully wettable) to 3 (clearly visible ring distortions in more than 1/3 of ring reflection zone). The total wettability score per eye was calculated by averaging the grade of each of the 5 corneal regions (central, superior, nasal, inferior, and temporal). One eye (right eye) contributed to the mean.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 44 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Sign Informed Consent.

• Adapted soft contact lens wearer.

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

• Vision correctable to 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.

• Contact lens prescription within the power range specified in the protocol.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

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

• Any use of systemic or ocular medications that would contraindicate contact lens wear.

• Any ocular finding observed during the Visit 1 examination that would contraindicate contact lens wear.

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

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

• Known pregnancy.

• Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses.

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

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Jessie Lemp, PhD, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01839318
• Other Study ID Numbers: A01336
• First Posted: Apr 24, 2013
• Last Update Posted: Jun 20, 2014
• Last Verified: May 1, 2014

• Keywords provided by Alcon Research: Soft contact lenses; Daily disposable contact lenses; Tear Film Break Up Time; Contact lens wettability
• Additional relevant MeSH terms: Refractive Errors; Hyperopia

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 1 study center located in Germany.
Pre-assignment Detail	Of the 30 enrolled, 2 participants discontinued before product was dispensed. This reporting group includes all participants exposed to the study product (28). In this 3-treatment, 6-sequence crossover study, each participant received all 3 products in randomized order and used 1 product at a time for a duration of 12 hours.

Arm/Group Title	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Sequence 5	Sequence 6
Arm/Group Description	Omafilcon A contact lenses worn first, followed by nelfilcon A contact lenses worn second, then etafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.	Omafilcon A contact lenses worn first, followed by etafilcon A contact lenses worn second, then nelfilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.	Nelfilcon A contact lenses worn first, followed by etafilcon A contact lenses worn second, then omafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.	Nelfilcon A contact lenses worn first, followed by omafilcon A contact lenses worn second, then etafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.	Etafilcon A contact lenses worn first, followed by omafilcon A contact lenses worn second, then nelfilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.	Etafilcon A contact lenses worn first, followed by nelfilcon A contact lenses worn second, then omafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
Period Title: Period 1, First Day of Wear
STARTED	4	4	5	6	7	2
COMPLETED	4	4	5	6	7	2
NOT COMPLETED	0	0	0	0	0	0
Period Title: Period 1, First Day of Wear
STARTED	4	4	5	6	7	2
COMPLETED	4	4	5	6	7	2
NOT COMPLETED	0	0	0	0	0	0
Period Title: Period 1, First Day of Wear
STARTED	4	4	5	6	7	2
COMPLETED	4	4	5	6	7	2
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Nelfilcon A contact lenses, etafilcon A contact lenses, and omafilcon A contact lenses worn in a cross-over assignment.
Overall Participants	28
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24.96 (3.54)
Sex: Female, Male (Count of Participants)
Female	22 78.6%
Male	6 21.4%

Outcome Measures

1. Primary Outcome

Title	Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours
Description	The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean.
Time Frame	Hour 8

Outcome Measure Data

Analysis Population Description

This analysis population includes all participants exposed to the study product with reportable values.

Arm/Group Title	DAILIES AquaComfort Plus	1-DAY ACUVUE MOIST	Proclear 1 Day
Arm/Group Description	Nelfilcon A contact lenses worn in a randomized order for 1 day, 12 hours	Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours	Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
Measure Participants	27	26	27
Mean (Standard Deviation) [seconds]	5.28 (5.71)	3.46 (4.52)	4.93 (6.34)

2. Secondary Outcome

Title	Total Wettability Score
Description	The investigator graded lens wettability by corneal region using a scale from 0 (fully wettable) to 3 (clearly visible ring distortions in more than 1/3 of ring reflection zone). The total wettability score per eye was calculated by averaging the grade of each of the 5 corneal regions (central, superior, nasal, inferior, and temporal). One eye (right eye) contributed to the mean.
Time Frame	Hour 8

Outcome Measure Data

Analysis Population Description

This analysis population includes all participants exposed to the study product with reportable values.

Arm/Group Title	DAILIES AquaComfort Plus	1-DAY ACUVUE MOIST	Proclear 1 Day
Arm/Group Description	Nelfilcon A contact lenses worn in a randomized order for 1 day, 12 hours	Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours	Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
Measure Participants	27	26	27
5 seconds post blink	0.74 (0.93)	0.83 (0.87)	0.84 (0.96)
10 seconds post blink	1.25 (1.15)	1.20 (1.14)	1.42 (1.2)
15 seconds post blink	1.58 (1.2)	1.54 (1.21)	1.66 (1.19)
20 seconds post blink	1.69 (1.21)	1.78 (1.22)	1.89 (1.18)
25 seconds post blink	1.79 (1.18)	1.94 (1.19)	2.03 (1.17)

Adverse Events

Time Frame	Adverse events (AEs) were collected for the duration of the study (2 months). This analysis group includes all enrolled participants.
Adverse Event Reporting Description	An AE is 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 medical device.
Arm/Group Title	DAILIES AquaComfort Plus		1-DAY ACUVUE MOIST		Proclear 1 Day
Arm/Group Description	Nelfilcon A contact lenses worn in a randomized order for 1 day, 12 hours		Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours		Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
All Cause Mortality
	DAILIES AquaComfort Plus		1-DAY ACUVUE MOIST		Proclear 1 Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	DAILIES AquaComfort Plus		1-DAY ACUVUE MOIST		Proclear 1 Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	DAILIES AquaComfort Plus		1-DAY ACUVUE MOIST		Proclear 1 Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/30 (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.