Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01629693
First received: June 26, 2012
Last updated: November 22, 2013
Last verified: November 2013
  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:


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.


Enrollment: 398
Study Start Date: May 2013
Study Completion Date: November 2013
Primary Completion Date: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
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: November 22, 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 July 20, 2014