A Prospective Study of Two Daily Disposable Contact Lenses

NCT01636986 | Completed Results

• 1 other identifier: A00930
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myopia

Keywords

myopia; contact lenses; dry eyes; comfort; replacement

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ

  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.

  Day 0, Week 4

Study Arms (2)

DT1

EXPERIMENTAL

Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks

Device: Delefilcon A contact lenses

1DAVM

ACTIVE COMPARATOR

Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks

Device: Etafilcon A contact lenses

Interventions

Delefilcon A contact lenses DEVICE

Silicone hydrogel contact lenses for daily wear, daily disposable use

Also known as: DAILIES TOTAL1®

DT1

Etafilcon A contact lenses DEVICE

Hydrogel contact lenses for daily wear, daily disposable use

Also known as: 1-DAY ACUVUE® MOIST™

1DAVM

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Myopia; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Lacrimal Apparatus Diseases

Limitations and Caveats

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

Results Point of Contact

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

alcon.medinfo@alcon.com

1-888-452-3937

Study Officials

• Jami Kern, Ph.D.

  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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 10, 2012
• Study Start: July 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 14, 2014
• Results First Posted: January 14, 2014

Record last verified: 2013-11