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

NCT01614600 | Completed Results DMC

• 1 other identifier: A00849
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Dry Eye Syndrome; Myopia

Keywords

contact lens; dry eye syndrome; symptomatic; daily disposable; myopia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

DAILIES® AquaComfort Plus®

EXPERIMENTAL

Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks

Device: Nelfilcon A contact lenses

Interventions

Nelfilcon A contact lenses DEVICE

Commercially marketed hydrogel contact lenses for daily wear, daily disposable use

Also known as: DAILIES® AquaComfort Plus®

DAILIES® AquaComfort Plus®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Dry Eye Syndromes; Myopia

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Refractive Errors

Results Point of Contact

• Title: Jami Kern, MBA, PhD
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Jami Kern, MBA, PhD

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 8, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 4, 2013
• Results First Posted: December 4, 2013

Record last verified: 2013-09