Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

NCT01634659 | Completed Results

• 1 other identifier: M-12-033
• Study Type: interventional
• Target: 330
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to compare the subjective performance of DAILIES TOTAL1® daily disposable contact lenses to that of 1-DAY ACUVUE® TruEye® daily disposable contact lenses.

Conditions

Myopia

Keywords

contact lenses; myopia

Outcome Measures

Primary Outcomes (1)

• Overall Comfort

  Overall comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.

  Day 8

Secondary Outcomes (2)

• Overall Quality of Vision

  Day 8

• End of Day Comfort

  Day 8

Study Arms (2)

Delefilcon A, then narafilcon B

OTHER

Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.

Device: Delefilcon A contact lenses (DAILIES TOTAL1®); Device: Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)

Narafilcon B, then delefilcon A

OTHER

Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.

Device: Delefilcon A contact lenses (DAILIES TOTAL1®); Device: Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)

Interventions

Delefilcon A contact lenses (DAILIES TOTAL1®) DEVICE

Commercially marketed silicone hydrogel, single-vision contact lenses for daily wear, daily disposable use

Delefilcon A, then narafilcon B; Narafilcon B, then delefilcon A

Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) DEVICE

Commercially marketed, silicone hydrogel single-vision contact lenses for daily wear, daily disposable use

Delefilcon A, then narafilcon B; Narafilcon B, then delefilcon A

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 and HIPAA form.
• Be current weekly/monthly replacement contact lens wearer.
• Be willing to not sleep in contact lenses during the study period.
• Require vision correction in both eyes, with a contact lens prescription in protocol-specified power range.
• Have best corrected visual acuity of at least 20/25 in each eye.
• Be willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
• Use re-wetting drops less than once per day and be willing to discontinue use of rewetting drops while wearing the study contact lenses.

You may not qualify if:

• Be a neophyte or current wearer of daily disposable lenses.
• Require monovision correction or use multifocal contact lenses.
• Have any systemic or ocular disease or disorder, complicating factor, or structural abnormality that would negatively affect the conduct or outcome of the study.
• Have a history of ocular surgery/trauma within the last 6 months.
• Use topical ocular or systemic antibiotics within 7 days of enrollment.
• Use topical ocular or systemic corticosteroids within 14 days of enrollment, continuing throughout the study.
• Have participated in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
• Have habitually worn contact lenses on an extended wear basis (sleeping in habitual contact lenses for at least 2 nights per week) in the last 3 months prior to enrollment.
• Use re-wetting drops once or more per day.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 6, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 24, 2013
• Results First Posted: November 28, 2013

Record last verified: 2013-11