A Prospective Study of Two Daily Disposable Contact Lenses

NCT ID: NCT01636986

Last Updated: 2014-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2012-11-30

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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DT1

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

Group Type: EXPERIMENTAL

Delefilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for daily wear, daily disposable use

1DAVM

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

Group Type: ACTIVE_COMPARATOR

Etafilcon A contact lenses

Intervention Type: DEVICE

Hydrogel contact lenses for daily wear, daily disposable use

Interventions

Delefilcon A contact lenses

Silicone hydrogel contact lenses for daily wear, daily disposable use

Intervention Type: DEVICE

Etafilcon A contact lenses

Hydrogel contact lenses for daily wear, daily disposable use

Intervention Type: DEVICE

Other Intervention Names

DAILIES TOTAL1®; 1-DAY ACUVUE® MOIST™

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jami Kern, Ph.D.

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

A00930

Identifier Type: -

Identifier Source: org_study_id