A Prospective Study of Two Daily Disposable Contact Lenses

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01636986
• Collaborator: (none)
• Enrollment: 62
• Arms: 2
• Duration (Months): 4

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate the performance of a novel silicone hydrogel contact lens, DAILIES TOTAL1® (DT1) compared to the standard hydrogel material in 1-DAY ACUVUE® MOIST® (1DAVM) contact lens in contact lens wearers identified as having contact lens-related dryness symptoms.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Delefilcon A contact lenses; Device: Etafilcon A contact lenses	N/A

Detailed Description

Three study visits occurred over the course of 28 ± 3 days.

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Impact of a Novel Silicone Hydrogel in Reducing Contact Lens-Related Dryness Symptoms in Existing Contact Lens Wearers
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DT1 Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks	Device: Delefilcon A contact lenses; Silicone hydrogel contact lenses for daily wear, daily disposable use; Other Names: DAILIES TOTAL1®
Active Comparator: 1DAVM Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks	Device: Etafilcon A contact lenses; Hydrogel contact lenses for daily wear, daily disposable use; Other Names: 1-DAY ACUVUE® MOIST™

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ [Day 0, Week 4]

   Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 43 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Be of legal age of consent and sign written Informed Consent Document and HIPAA form.

• Currently wearing soft contact lenses and identified as having contact lens-related dryness symptoms based upon responses to the Contact Lens Dry Eye Questionnaire.

• Wearing either daily disposable contact lenses or bi-weekly/monthly replacement contact lenses, daily wear use only (no extended wear use).

• Able to achieve distance visual acuity of at least 20/25 in each eye with study lenses in the available parameters, -0.50D to -6.00D.

• Willing to wear study lenses for at least 8 hours/day and at least 5 days/week.

• Willing and able to follow instructions and maintain the appointment schedule.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Neophyte or current wearer of DAILIES TOTAL1® or 1-DAY ACUVUE® MOIST™ contact lenses.

• Requires monovision or presbyopic correction.

• Any systemic or ocular disease or disorder complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.

• Recent (within 7 days of enrollment) or current ocular infection, active ocular inflammation, glaucoma or preauricular lymphadenopathy.

• Clinically significant lash or lid abnormality.

• Systemic disease that, in the investigator's best judgment, would prohibit or confound safe contact lens wear.

• History of ocular surgery/trauma within the last 6 months.

• Topical or systemic antibiotics use within 7 days of enrollment.

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Jami Kern, Ph.D., Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01636986
• Other Study ID Numbers: A00930
• First Posted: Jul 10, 2012
• Last Update Posted: Jan 14, 2014
• Last Verified: Nov 1, 2013

• Keywords provided by Alcon Research: myopia; contact lenses; dry eyes; comfort; replacement
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 1 US study center.
Pre-assignment Detail	This reporting group includes all enrolled and randomized participants.

Arm/Group Title	DAILIES TOTAL1	1DAVM
Arm/Group Description	Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks	Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
Period Title: Overall Study
STARTED	30	32
COMPLETED	30	30
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	DAILIES TOTAL1	1DAVM	Total
Arm/Group Description	Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks	Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks	Total of all reporting groups
Overall Participants	30	30	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23.26 (4.28)	24.53 (4.83)	23.89 (4.56)
Sex: Female, Male (Count of Participants)
Female	23 76.7%	24 80%	47 78.3%
Male	7 23.3%	6 20%	13 21.7%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ
Description	Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom.
Time Frame	Day 0, Week 4

Outcome Measure Data

Analysis Population Description

All enrolled and randomized participants who completed the study.

Arm/Group Title	DAILIES TOTAL1	1DAVM
Arm/Group Description	Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks	Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
Measure Participants	30	30
Eyes feel uncomfortable	-0.21 (0.13)	-0.17 (0.16)
Eyes feel dry	-1.07 (0.68)	-0.92 (0.90)
Vision change between clear and blurry	-0.04 (0.04)	-0.04 (0.04)
Eyes feel irritated	-0.42 (0.32)	-0.31 (0.28)
Eyes feel gritty and scratchy	-0.10 (0.10)	-0.07 (0.07)
Feel "something" in the eye	-0.47 (0.58)	-0.38 (0.54)
Eyes burning and stinging	-0.25 (0.34)	-0.28 (0.36)
Eyes feel unusually sensitive to bright light	-0.23 (0.35)	-0.19 (0.32)
Eyes itch	-0.43 (0.41)	-0.38 (0.46)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study (4 months).
Adverse Event Reporting Description	This reporting group includes all enrolled participants who were exposed to the test product.
Arm/Group Title	DAILIES TOTAL1		1DAVM
Arm/Group Description	Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks		Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
All Cause Mortality
	DAILIES TOTAL1		1DAVM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	DAILIES TOTAL1		1DAVM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	DAILIES TOTAL1		1DAVM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/30 (23.3%)		8/32 (25%)
Eye disorders
Contact lens fell out	0/30 (0%)		2/32 (6.3%)
Eye irritation	4/30 (13.3%)		4/32 (12.5%)
Corneal Staining	1/30 (3.3%)		2/32 (6.3%)
Foreign body sensation	2/30 (6.7%)		0/32 (0%)

Limitations/Caveats

The study was not powered to detect differences in individual items.

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.