Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses

NCT01629693 | Completed Results

• 1 other identifier: A00973
• Study Type: interventional
• Target: 398
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate differences in the comfort at the end of the month between Air Optix® lenses versus Biofinity® lenses in habitual daily wear symptomatic soft contact lens wearers.

Conditions

Myopia; Astigmatism

Keywords

contact lenses; myopia; astigmatism

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30

  Overall comfort was assessed by the participant as a response to the questionnaire item 'I can comfortably wear my lenses', using a 10-point Likert scale, with 1=poor and 10=excellent.

  Baseline, Day 30

Study Arms (2)

Air Optix

EXPERIMENTAL

Lotrafilcon B contact lenses worn bilaterally (in both eyes) for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis (removed nightly for cleaning and disinfection).

Device: Lotrafilcon B contact lenses

Biofinity

ACTIVE COMPARATOR

Comfilcon A contact lenses worn bilaterally (in both eyes) for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis (removed nightly for cleaning and disinfection).

Device: Comfilcon A contact lenses

Interventions

Lotrafilcon B contact lenses DEVICE

Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription

Also known as: AIR OPTIX® AQUA, AIR OPTIX® for ASTIGMATISM

Air Optix

Comfilcon A contact lenses DEVICE

Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription

Also known as: Biofinity® Sphere, Biofinity® Toric

Biofinity

Eligibility Criteria

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

You may qualify if:

• Must sign written informed consent document.
• Currently wearing weekly/biweekly or monthly sphere or toric soft contact lenses (NOT including AIR OPTIX Aqua, AIR OPTIX NIGHT \& DAY Aqua, AIR OPTIX for Astigmatism, Biofinity Sphere, Biofinity Toric, or ProClear Toric soft contact lenses) bilaterrally (in both eyes) and have worn these lenses for at least 3 months, daily wear use only (no extended wear).
• Symptomatic for contact lens-related ocular discomfort at the end of the lens wearing day.
• Current contact lens prescription within the available parameters of both study products.
• Able to achieve visual acuity (VA) of at least 6/7.5 (20/25) in each eye with study lenses in the available parameters.
• Willing to wear study lenses for at least 4 hours/day and at least 5 days/week for the 1 month trial period.
• Willing and able to follow instructions, study procedures and maintain the appointment schedule.

You may not qualify if:

• Neophytes and current wearers of AIR OPTIX Aqua, AIR OPTIX NIGHT \& DAY Aqua, AIR OPTIX for Astigmatism, Biofinity sphere, Biofinity Toric, or ProClear Toric soft contact lenses.
• Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye is permitted), 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 infections, active ocular inflammation, glaucoma or preauricular lymphadenopathy.
• A history of ocular surgery/trauma within the last 6 months.
• Topical or systemic antibiotics use within 7 days of enrollment.
• Topical ocular or systemic corticosteroids use within 14 days of enrollment.
• Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jessie Lemp, GMA Affairs Lead
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

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: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: June 28, 2012
• Study Start: July 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 6, 2014
• Results First Posted: November 6, 2014

Record last verified: 2014-10