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

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).

Study Overview

• Status: Completed
• Conditions: Myopia; Dry Eye Syndrome
• Intervention / Treatment: Device: Nelfilcon A contact lenses

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and 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.	Baseline, Week 1, Week 2

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Jami Kern, MBA, PhD, Alcon Research

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: June 6, 2012
• First Submitted That Met QC Criteria: June 6, 2012
• First Posted (Estimate): June 8, 2012

Study Record Updates

• Last Update Posted (Estimate): December 4, 2013
• Last Update Submitted That Met QC Criteria: September 27, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: contact lens; myopia; symptomatic; dry eye syndrome; daily disposable
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Refractive Errors; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Myopia
• Other Study ID Numbers: A00849