Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

NCT01561560 | Completed Results

• 1 other identifier: P-347-C-019
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this crossover study was to evaluate the end-of-day comfort of two commercially available, daily disposable, silicone hydrogel contact lenses.

Conditions

Myopia

Keywords

DAILIES TOTAL1; contact lenses; myopia

Outcome Measures

Primary Outcomes (1)

• End-of-day Comfort

  End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, "Please rate the study lenses you have been wearing the in the following area: End-of-day comfort" and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent).

  Week 2

Study Arms (2)

DAILIES TOTAL1, then TRUEYE

OTHER

Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.

Device: Delefilcon A contact lenses; Device: Narafilcon A contact lenses

TRUEYE, then DAILIES TOTAL1

OTHER

Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.

Device: Delefilcon A contact lenses; Device: Narafilcon A contact lenses

Interventions

Delefilcon A contact lenses DEVICE

CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two

Also known as: DAILIES TOTAL1®

DAILIES TOTAL1, then TRUEYE; TRUEYE, then DAILIES TOTAL1

Narafilcon A contact lenses DEVICE

CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two

Also known as: 1-DAY ACUVUE® TRUEYE™

DAILIES TOTAL1, then TRUEYE; TRUEYE, then DAILIES TOTAL1

Eligibility Criteria

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

You may qualify if:

• Sign written Informed Consent Document.
• Currently wearing soft contact lenses in both eyes and identified as symptomatic based on questionnaire responses.
• Currently wearing either daily disposable contact lenses or weekly/monthly replacement contact lenses.
• Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses in the available parameters.
• Willing to wear study lenses for at least eight hours per day and at least five days per week.

You may not qualify if:

• Has not worn contact lenses before.
• Currently wearing DAILIES TOTAL1 or 1-DAY ACUVUE TRUEYE contact lenses.
• Any systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
• Ocular surgery/trauma within the last six months.
• Topical ocular or systemic use of antibiotics within seven days of enrollment.
• Pregnant or nursing women.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

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

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Camille Girault

  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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2012
• First Posted: March 23, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 7, 2014
• Results First Posted: January 7, 2014

Record last verified: 2013-11

Locations

US (1)