DAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02517567
• Collaborator: (none)
• Enrollment: 37
• Arms: 4
• Actual Duration (Months): 7

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the tear film evaporation of symptomatic soft contact lens wearers in the absence of contact lens wear and after at least 8 hours of contact lens wear.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error	Device: Delefilcon A contact lenses; Device: Narafilcon A contact lenses; Device: Somofilcon A contact lenses	N/A

Detailed Description

This study consists of 5 visits (1 screening, 4 assessment) with a maximum of 6 days between assessment visits and at least 24 hours of no lens wear the day prior to the visit. Each subject will be randomized to a crossover sequence of 4 periods. Different study lenses will be worn during 3 of the periods, for at least 8 hours each, and the remaining period will have no lens wear.

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Pilot Study on the Effect of Daily Disposable Silicone Hydrogel Contact Lenses on Tear Film Lipids
• Actual Study Start Date: Sep 21, 2015
• Actual Primary Completion Date: Apr 22, 2016
• Actual Study Completion Date: Apr 22, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Sequence 1 Delefilcon A, then narafilcon A, then somofilcon A, then no lens wear. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.	Device: Delefilcon A contact lenses; Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions; Other Names: DAILIES TOTAL1® ; Device: Narafilcon A contact lenses; Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions; Other Names: 1-DAY ACUVUE® TruEye® ; Device: Somofilcon A contact lenses; Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions; Other Names: clariti® 1 day
Other: Sequence 2 Narafilcon A, then no lens wear, then delefilcon A, then somofilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.	Device: Delefilcon A contact lenses; Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions; Other Names: DAILIES TOTAL1® ; Device: Narafilcon A contact lenses; Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions; Other Names: 1-DAY ACUVUE® TruEye® ; Device: Somofilcon A contact lenses; Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions; Other Names: clariti® 1 day
Other: Sequence 3 Somofilcon A, then delefilcon A, then no lens wear, then narafilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.	Device: Delefilcon A contact lenses; Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions; Other Names: DAILIES TOTAL1® ; Device: Narafilcon A contact lenses; Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions; Other Names: 1-DAY ACUVUE® TruEye® ; Device: Somofilcon A contact lenses; Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions; Other Names: clariti® 1 day
Other: Sequence 4 No lens wear, then somofilcon A, then narafilcon A, then delefilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.	Device: Delefilcon A contact lenses; Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions; Other Names: DAILIES TOTAL1® ; Device: Narafilcon A contact lenses; Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions; Other Names: 1-DAY ACUVUE® TruEye® ; Device: Somofilcon A contact lenses; Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions; Other Names: clariti® 1 day

Outcome Measures

Primary Outcome Measures

1. Tear Film Evaporation Rate [Day 1, Hour 8, each product]

   Tear film evaporation rate (amount of tears (grams or g) that evaporates over a surface area (m2) per hour (h)) assessment was performed using the VapoMeter as a non-invasive measurement of tear film evaporation over 10 seconds. Measurements were taken on both the right and left eyes after 8 hours of lens wear or no lens wear, as applicable. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Sign an informed consent document;

• Adapted, current soft contact lens wearer;

• Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;

• Can be successfully fitted with study lenses;

• Willing to wear lenses for a minimum of 8 hours prior to each study visit;

• Willing to discontinue artificial tears and rewetting drops usage on the days of study visits;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• 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;

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

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

• Known pregnancy and lactation;

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Clinical Manager, Clinical Trial Management, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02517567
• Other Study ID Numbers: CLT978-P001
• First Posted: Aug 7, 2015
• Last Update Posted: Jul 2, 2018
• Last Verified: Jul 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 1 study center located in Australia.
Pre-assignment Detail	Of the 37 enrolled, 7 subjects were exited as screen failures prior to randomization and 1 subject discontinued after randomization prior to exposure to the investigational product. This reporting group includes all randomized and exposed subjects (29).

Arm/Group Title	Sequence 1	Sequence 2	Sequence 3	Sequence 4
Arm/Group Description	DAILIES TOTAL1 (DT1)/TruEye/clariti/No Lens	TruEye/No Lens/DT1/clariti	clariti/DT1/No Lens/TruEye	No Lens/clariti/TruEye/DT1
Period Title: First Exposure (8 Hours)
STARTED	6	8	7	8
COMPLETED	6	8	7	8
NOT COMPLETED	0	0	0	0
Period Title: First Exposure (8 Hours)
STARTED	6	8	7	8
COMPLETED	6	8	7	8
NOT COMPLETED	0	0	0	0
Period Title: First Exposure (8 Hours)
STARTED	6	8	7	8
COMPLETED	6	8	7	8
NOT COMPLETED	0	0	0	0
Period Title: First Exposure (8 Hours)
STARTED	6	8	6	8
COMPLETED	6	8	6	8
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Delefilcon A, narafilcon A, and somofilcon A contact lenses worn bilaterally (in both eyes) and a period of no lens wear in a randomized crossover fashion
Overall Participants	29
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23.7 (5.36)
Sex: Female, Male (Count of Participants)
Female	21 72.4%
Male	8 27.6%

Outcome Measures

1. Primary Outcome

Title	Tear Film Evaporation Rate
Description	Tear film evaporation rate (amount of tears (grams or g) that evaporates over a surface area (m2) per hour (h)) assessment was performed using the VapoMeter as a non-invasive measurement of tear film evaporation over 10 seconds. Measurements were taken on both the right and left eyes after 8 hours of lens wear or no lens wear, as applicable. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.
Time Frame	Day 1, Hour 8, each product

Outcome Measure Data

Analysis Population Description

This analysis population includes all randomized subjects (Intent-to-Treat). To address the primary objective of comparing Lens vs. No Lens, results from all 3 study lenses are combined. Therefore, subjects (eyes) are counted multiple times in Lens group due to crossover design and number of eyes with non-missing response is reported.

Arm/Group Title	Lens	No Lens
Arm/Group Description	Delefilcon A contact lenses, narafilcon A contact lenses, and somofilcon A contact lenses worn bilaterally in cross-over fashion as randomized. Each product worn for one day, 8 hours minimum.	One 8-hour day of no lens wear as part of the crossover sequence
Measure Participants	29	29
Measure Eyes	172	58
Mean (Standard Deviation) [gm^-2 h]	120.88 (45.563)	105.63 (53.361)

Adverse Events

Time Frame	Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 5 weeks). AEs are reported as pretreatment and treatment-emergent.
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 medical device.
Arm/Group Title	Pretreatment		DAILIES TOTAL1		TruEye		Clariti		No Lens
Arm/Group Description	All subjects who consented to participate in the study prior to exposure to the investigational product (including the 'No Lens wear' treatment)		All subjects exposed to DT1 contact lenses worn for 8 hours during Period 1, 2, 3, or 4 as randomized		All subjects exposed to TruEye contact lenses worn for 8 hours during Period 1, 2, 3, or 4 as randomized		All subjects exposed to clariti contact lenses worn for 8 hours during Period 1, 2, 3, or 4 as randomized		All subjects exposed to "No lens wear" for 8 hours during Period 1, 2, 3, or 4 as randomized
All Cause Mortality
	Pretreatment		DAILIES TOTAL1		TruEye		Clariti		No Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/29 (0%)		0/28 (0%)		0/29 (0%)		0/29 (0%)
Serious Adverse Events
	Pretreatment		DAILIES TOTAL1		TruEye		Clariti		No Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/29 (0%)		0/28 (0%)		0/29 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Pretreatment		DAILIES TOTAL1		TruEye		Clariti		No Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/29 (0%)		0/28 (0%)		0/29 (0%)		0/29 (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.