A Prospective Study of Two Daily Disposable Contact Lenses

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Delefilcon A contact lenses; Device: Etafilcon A contact lenses

• Registration Number: NCT01636986
• Lead Sponsor: Alcon Research

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.

Detailed Description

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

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-06
• Study First Posted: 2012-07-10
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-11
• Results First Submitted: 2013-11-25
• Results First Submitted QC: 2013-11-25
• Last Update Submitted: 2013-11-25
• Results First Posted: 2014-01-14
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DT1	Delefilcon A contact lenses	Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
1DAVM	Etafilcon A contact lenses	Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks

Primary Outcome Measures

Name	Time	Method
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.