Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01614600
• Collaborator: (none)
• Enrollment: 88
• Arm: 1
• Duration (Months): 3

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate the reduction of contact lens-related dryness symptoms when symptomatic weekly/monthly contact lens wearers were switched to DAILIES® AquaComfort Plus® lenses for a two-week period using composite scores on the Contact Lens Dry Eye Questionnaire (CLDEQ).

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome; Myopia	Device: Nelfilcon A contact lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DAILIES® AquaComfort Plus® Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks	Device: Nelfilcon A contact lenses; Commercially marketed hydrogel contact lenses for daily wear, daily disposable use; Other Names: DAILIES® AquaComfort Plus®

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2 [Baseline, Week 1, Week 2]

   Contact lens symptoms were evaluated using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects rated 8 common contact lens-related ocular surface dryness symptoms at Baseline, Week 1, and Week 2 using a 5-point scale (1=never or not at all intense, 5=constantly or very intense). A scoring algorithm was used to calculate a composite score for each visit for all symptoms (-6.5 to 10). A higher composite score would indicate more contact lens related dry eye and a lower score, less contact lens related dry eye.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Currently wearing weekly/monthly, silicone hydrogel or traditional hydrogel soft contact lenses at least 8 hours per day and 5 days a week during the past 6 months.

• Identified as symptomatic using a baseline screening questionnaire.

• Requires vision correction in both eyes with a contact lens prescription as follows: sphere powers between -0.50 and -10.00 diopter (D) and cylinder powers </= 0.75D and no ADD correction.

• Able to achieve visual acuity (VA) of at least 6/7.5 in each eye with study lenses in the available parameters.

• Willing to wear study lenses for at least 8 hours/day and at least 5 days/week and discard the lenses at the end of the day and replace lenses every day with a new fresh pair.

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

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Neophytes and current wearers of daily disposable contact lenses.

• Requires monovision correction.

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

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

• Unwilling to discontinue mechanical eyelid therapy or eyelid scrubs within 14 days of enrollment and continuing during the study.

• Participation in any other ophthalmic drug or device clinical trial within 30 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, MBA, PhD, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01614600
• Other Study ID Numbers: A00849
• First Posted: Jun 8, 2012
• Last Update Posted: Dec 4, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by Alcon Research: contact lens; dry eye syndrome; symptomatic; daily disposable; myopia
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Myopia

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 8 study centers located in the United States.
Pre-assignment Detail	Of the 91 participants enrolled, 3 were exited as screen failures prior to dispensing of the study product. This reporting group includes all enrolled and dispensed participants.

Arm/Group Title	DAILIES® AquaComfort Plus®
Arm/Group Description	Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
Period Title: Overall Study
STARTED	88
COMPLETED	84
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	DAILIES® AquaComfort Plus®
Arm/Group Description	Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
Overall Participants	88
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.2 (9.0)
Sex: Female, Male (Count of Participants)
Female	66 75%
Male	22 25%
Region of Enrollment (participants) [Number]
United States	88 100%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2
Description	Contact lens symptoms were evaluated using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects rated 8 common contact lens-related ocular surface dryness symptoms at Baseline, Week 1, and Week 2 using a 5-point scale (1=never or not at all intense, 5=constantly or very intense). A scoring algorithm was used to calculate a composite score for each visit for all symptoms (-6.5 to 10). A higher composite score would indicate more contact lens related dry eye and a lower score, less contact lens related dry eye.
Time Frame	Baseline, Week 1, Week 2

Outcome Measure Data

Analysis Population Description

Per Protocol: All enrolled and dispensed participants, minus any major protocol deviators as determined by masked review.

Arm/Group Title	DAILIES® AquaComfort Plus®
Arm/Group Description	Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
Measure Participants	74
Change from Baseline at Week 1	-0.09 (1.24)
Change from Baseline at Week 2	-0.29 (1.06)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study (3 months).
Adverse Event Reporting Description	This reporting group includes all enrolled and dispensed participants.
Arm/Group Title	DAILIES® AquaComfort Plus®
Arm/Group Description	Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
All Cause Mortality
	DAILIES® AquaComfort Plus®
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	DAILIES® AquaComfort Plus®
	Affected / at Risk (%)	# Events
Total	0/88 (0%)
Other (Not Including Serious) Adverse Events
	DAILIES® AquaComfort Plus®
	Affected / at Risk (%)	# Events
Total	0/88 (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.