Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 3, 2014
Last verified: October 2014
  Purpose

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 Intervention
Myopia
Astigmatism
Device: Lotrafilcon B contact lenses
Device: Comfilcon A contact lenses

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:
  • Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30 [ Time Frame: Baseline, Day 30 ] [ Designated as safety issue: No ]
    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.


Enrollment: 398
Study Start Date: July 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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

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
Results First Received: November 3, 2014
Last Updated: November 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
contact lenses
myopia
astigmatism

Additional relevant MeSH terms:
Astigmatism
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on November 20, 2014