Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Myopia; Astigmatism	Device: Lotrafilcon B contact lenses; Device: Comfilcon A contact lenses	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	398 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Official Title:	Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses
Study Start Date :	July 2013
Actual Primary Completion Date :	November 2013
Actual Study Completion Date :	November 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 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).	Device: Lotrafilcon B contact lenses; Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription; Other Names: AIR OPTIX® AQUA; AIR OPTIX® for ASTIGMATISM
Active Comparator: 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).	Device: Comfilcon A contact lenses; Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription; Other Names: Biofinity® Sphere; Biofinity® Toric

Outcome Measures

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Primary Outcome Measures :

1. Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30 [ Time Frame: Baseline, 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.
• Other protocol-defined inclusion criteria may apply.

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.
• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Alcon Research

Investigators

Study Director:	Jami Kern, Ph.D.	Alcon Research

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT01629693 History of Changes
Other Study ID Numbers:	A00973
First Posted:	June 28, 2012
Results First Posted:	November 6, 2014
Last Update Posted:	November 6, 2014
Last Verified:	October 2014

Keywords provided by Alcon Research:

contact lenses; myopia; astigmatism

Additional relevant MeSH terms:

Myopia; Astigmatism; Refractive Errors; Eye Diseases