Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses - Full Text View

Purpose

The purpose of this study is evaluate the performance at the end of the month for two monthly replacement silicone hydrogel contact lenses.

Condition	Intervention
Myopia Astigmatism	Device: Lotrafilcon B contact lens, sphere Device: Lotrafilcon B contact lens, toric Device: Comfilcon A contact lens, sphere Device: Comfilcon A contact lens, toric

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Overall Comfort [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
Overall comfort will be interpreted and recorded by the subject on a questionnaire. Overall comfort will be graded on a continuous 1-10 scale, where 1=poor and 10=excellent.

Estimated Enrollment:	408
Study Start Date:	May 2013
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Air Optix Aqua After an initial adaptation period, a fresh pair of contact lenses will be dispensed and worn bilaterally for 4 weeks. The lenses will be worn at least hours a day, 5 days a week, and will be removed nightly for cleaning and disinfection.	Device: Lotrafilcon B contact lens, sphere Commercially marketed, silicone hydrogel, single vision contact lens worn for 4 weeks on a daily wear basis. Other Name: AIR OPTIX® AQUA
Experimental: Air Optix for Astigmatism After an initial adaptation period, a fresh pair of contact lenses will be dispensed and worn bilaterally for 4 weeks. The lenses will be worn at least hours a day, 5 days a week, and will be removed nightly for cleaning and disinfection.	Device: Lotrafilcon B contact lens, toric Commercially marketed, silicone hydrogel, toric contact lens worn for 4 weeks on a daily wear basis. Other Name: AIR OPTIX® for ASTIGMATISM
Active Comparator: Biofinity Sphere After an initial adaptation period, a fresh pair of contact lenses will be dispensed and worn bilaterally for 4 weeks. The lenses will be worn at least hours a day, 5 days a week, and will be removed nightly for cleaning and disinfection.	Device: Comfilcon A contact lens, sphere Commercially marketed, silicone hydrogel, single vision contact lens worn for 4 weeks on a daily wear basis. Other Name: Biofinity® Sphere
Active Comparator: Biofinity Toric After an initial adaptation period, a fresh pair of contact lenses will be dispensed and worn bilaterally for 4 weeks. The lenses will be worn at least hours a day, 5 days a week, and will be removed nightly for cleaning and disinfection.	Device: Comfilcon A contact lens, toric Commercially marketed, silicone hydrogel, toric contact lens worn for 4 weeks on a daily wear basis. Other Name: Biofinity® Toric

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Sign written Informed Consent Document and HIPAA form.
Currently wearing sphere or toric soft contact lenses and has worn these lenses for at least twelve (12) months, daily wear use only.
Symptomatic for contact lens-related ocular discomfort.
Current contact lens prescription within the available parameters of both study products.
Able to achieve visual acuity 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 8 hours/day and at least 5 days/week for the one month trial period.
Willing and able to follow instructions 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 continuing throughout the study.
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629693

Contacts

Contact: Alcon Call Center

1-888-451-3937

alcon.medinfo@alcon.com

Locations

United States, Texas
Contact Alcon Call Center for Trial Locations	Recruiting
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

Investigators

Study Director:

Jami Kern, Ph.D.

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT01629693 History of Changes
Other Study ID Numbers:	A00973
Study First Received:	June 26, 2012
Last Updated:	May 13, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Alcon Research:

contact lenses
myopia
astigmatism

Additional relevant MeSH terms:

Astigmatism
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 21, 2013