Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses

NCT ID: NCT01629693

Last Updated: 2014-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 398 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2013-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Air Optix

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).

Group Type: EXPERIMENTAL

Lotrafilcon B contact lenses

Intervention Type: DEVICE

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

Biofinity

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).

Group Type: ACTIVE_COMPARATOR

Comfilcon A contact lenses

Intervention Type: DEVICE

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

Interventions

Lotrafilcon B contact lenses

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

Intervention Type: DEVICE

Comfilcon A contact lenses

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

Intervention Type: DEVICE

Other Intervention Names

AIR OPTIX® AQUA; AIR OPTIX® for ASTIGMATISM; Biofinity® Sphere; Biofinity® Toric

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 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

A00973

Identifier Type: -

Identifier Source: org_study_id