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Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems

This study is currently recruiting participants.
Verified January 2013 by Alcon Research
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01699750
First received: October 2, 2012
Last updated: January 4, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the lipid uptake, wetting characteristics, and visual performance of AIR OPTIX® AQUA and ACUVUE® OASYS® with HYDRACLEAR® contact lenses when used in conjunction with two contact lens care systems, OPTI-FREE® PUREMOIST® MPDS and BIOTRUE®.


Condition Intervention
Myopia
Astigmatism
Refractive Error
 Device: Lotrafilcon B contact lenses (AIR OPTIX AQUA)
Device: Senofilcon A contact lenses (ACUVUE OASYS with HYDRACLEAR)
Device: OPTI-FREE PUREMOIST Multipurpose Disinfecting System (MPDS) contact lens care system
Device: BIOTRUE contact lens care system
Device: Balafilcon A contact lenses (PureVision)
Device: ReNu Multiplus contact lens care system

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Ex-Vivo Lipid Uptake [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Non-Invasive Tear Film Break Up Time [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • Time-Controlled Visual Acuity [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • Subjective Comfort [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • Dryness [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lotrafilcon B with Opti-Free Puremoist, then Biotrue
Lotrafilcon B contact lenses with OPTI-FREE PUREMOIST for 30 days, followed by BIOTRUE for an additional 30 days. A fresh pair of lenses was dispensed for each solution.
 Device: Lotrafilcon B contact lenses (AIR OPTIX AQUA)
Silicone hydrogel contact lenses worn on a daily wear basis and used with OPTI-FREE PUREMOIST or BIOTRUE lens care systems, 30 days each system, during Phase Two (Investigational Phase)
Other Name: AIR OPTIX® AQUA
Device: OPTI-FREE PUREMOIST Multipurpose Disinfecting System (MPDS) contact lens care system
Contact lens care system used with AIR OPTIX AQUA and ACUVUE OASYS WITH HYDRACLEAR contact lenses, 30 days each, during Phase Two (Investigational Phase)
Other Name: OPTI-FREE® PUREMOIST® MPDS
Device: BIOTRUE contact lens care system
Contact lens care system used with AIR OPTIX AQUA and ACUVUE OASYS WITH HYDRACLEAR contact lenses, 30 days each, during Phase Two (Investigational Phase)
Other Name: BIOTRUE®
Device: Balafilcon A contact lenses (PureVision)
Silicone hydrogel contact lenses worn on a daily wear basis for 30 days during Phase One (Pre-Investigational Phase).
Other Name: PureVision
Device: ReNu Multiplus contact lens care system
Contact lens care system used for 30 days during Phase One (Pre-Investigational Phase)
Other Name: ReNu Multiplus
Experimental: Lotrafilcon B with Biotrue, then Opti-Free Puremoist
Lotrafilcon B contact lenses with BIOTRUE for 30 days, followed by OPTI-FREE PUREMOIST for an additional 30 days. A fresh pair of lenses was dispensed for each solution.
 Device: Lotrafilcon B contact lenses (AIR OPTIX AQUA)
Silicone hydrogel contact lenses worn on a daily wear basis and used with OPTI-FREE PUREMOIST or BIOTRUE lens care systems, 30 days each system, during Phase Two (Investigational Phase)
Other Name: AIR OPTIX® AQUA
Device: OPTI-FREE PUREMOIST Multipurpose Disinfecting System (MPDS) contact lens care system
Contact lens care system used with AIR OPTIX AQUA and ACUVUE OASYS WITH HYDRACLEAR contact lenses, 30 days each, during Phase Two (Investigational Phase)
Other Name: OPTI-FREE® PUREMOIST® MPDS
Device: BIOTRUE contact lens care system
Contact lens care system used with AIR OPTIX AQUA and ACUVUE OASYS WITH HYDRACLEAR contact lenses, 30 days each, during Phase Two (Investigational Phase)
Other Name: BIOTRUE®
Device: Balafilcon A contact lenses (PureVision)
Silicone hydrogel contact lenses worn on a daily wear basis for 30 days during Phase One (Pre-Investigational Phase).
Other Name: PureVision
Device: ReNu Multiplus contact lens care system
Contact lens care system used for 30 days during Phase One (Pre-Investigational Phase)
Other Name: ReNu Multiplus
Active Comparator: Senofilcon A with Opti-Free Puremoist, then Biotrue
Senofilcon A contact lenses with OPTI-FREE PUREMOIST for 30 days, followed by BIOTRUE for an additional 30 days. A fresh pair of lenses will be dispensed for each solution, with biweekly replacement.
 Device: Senofilcon A contact lenses (ACUVUE OASYS with HYDRACLEAR)
Silicone hydrogel contact lenses worn on a daily wear basis and used with OPTI-FREE PUREMOIST or BIOTRUE lens care systems, 30 days each system, during Phase Two (Investigational Phase). Contact lenses replaced biweekly.
Other Name: ACUVUE® OASYS® with HYDRACLEAR®
Device: OPTI-FREE PUREMOIST Multipurpose Disinfecting System (MPDS) contact lens care system
Contact lens care system used with AIR OPTIX AQUA and ACUVUE OASYS WITH HYDRACLEAR contact lenses, 30 days each, during Phase Two (Investigational Phase)
Other Name: OPTI-FREE® PUREMOIST® MPDS
Device: BIOTRUE contact lens care system
Contact lens care system used with AIR OPTIX AQUA and ACUVUE OASYS WITH HYDRACLEAR contact lenses, 30 days each, during Phase Two (Investigational Phase)
Other Name: BIOTRUE®
Device: Balafilcon A contact lenses (PureVision)
Silicone hydrogel contact lenses worn on a daily wear basis for 30 days during Phase One (Pre-Investigational Phase).
Other Name: PureVision
Device: ReNu Multiplus contact lens care system
Contact lens care system used for 30 days during Phase One (Pre-Investigational Phase)
Other Name: ReNu Multiplus
Active Comparator: Senofilcon A with Biotrue, then Opti-Free Puremoist
Senofilcon A with BIOTRUE for 30 days, followed by OPTI-FREE PUREMOIST for an additional 30 days. A fresh pair of lenses will be dispensed for each solution, with biweekly replacement.
 Device: Senofilcon A contact lenses (ACUVUE OASYS with HYDRACLEAR)
Silicone hydrogel contact lenses worn on a daily wear basis and used with OPTI-FREE PUREMOIST or BIOTRUE lens care systems, 30 days each system, during Phase Two (Investigational Phase). Contact lenses replaced biweekly.
Other Name: ACUVUE® OASYS® with HYDRACLEAR®
Device: OPTI-FREE PUREMOIST Multipurpose Disinfecting System (MPDS) contact lens care system
Contact lens care system used with AIR OPTIX AQUA and ACUVUE OASYS WITH HYDRACLEAR contact lenses, 30 days each, during Phase Two (Investigational Phase)
Other Name: OPTI-FREE® PUREMOIST® MPDS
Device: BIOTRUE contact lens care system
Contact lens care system used with AIR OPTIX AQUA and ACUVUE OASYS WITH HYDRACLEAR contact lenses, 30 days each, during Phase Two (Investigational Phase)
Other Name: BIOTRUE®
Device: Balafilcon A contact lenses (PureVision)
Silicone hydrogel contact lenses worn on a daily wear basis for 30 days during Phase One (Pre-Investigational Phase).
Other Name: PureVision
Device: ReNu Multiplus contact lens care system
Contact lens care system used for 30 days during Phase One (Pre-Investigational Phase)
Other Name: ReNu Multiplus

Detailed Description:

This study will be divided into two phases, a pre-investigational screening phase and an investigational phase. During the pre-investigational screening phase, all participants will use PureVision contact lenses and ReNu Multiplus multipurpose solution per manufacturers' guidelines for 30 days. Eligible participants will continue into the investigational phase and will be randomly assigned to wear Air Optix Aqua or Oasys lenses with two months randomized crossover of contact lens care (one month each of Opti-Free PureMoist MPDS and Biotrue MPS).

  Eligibility

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

Inclusion Criteria:

  • Read and understand the Participant Information Sheet;
  • Read, sign, and date the Informed Consent;
  • Be a current silicone hydrogel contact lens wearer using the contact lenses under a frequent replacement (bi-weekly or monthly) daily wear modality;
  • Be classified as symptomatic and a depositor at the end of the replacement period according to protocol-specified criteria;
  • Agree to wear study contact lenses as directed for the duration of the study and maintain the appointment schedule;
  • Best corrected visual acuity of 6/9 or better in each eye;
  • Normal eyes with the exception of the need for visual correction;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used;
  • Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses);
  • Use of systemic medication which might interfere with contact lens wear or produce dry eye side effects;
  • Systemic disease which might interfere with contact lens wear or produce dry eye side effects;
  • Systemic or ocular allergies which might interfere with contact lens wear;
  • Ocular disease which might interfere with contact lens wear;
  • Active ocular infection;
  • Use of any concomitant topical ocular medications during the study period;
  • Previous ocular surgery;
  • Pregnant, planning to become pregnant, or lactating at the time of enrollment;
  • Participation in an investigational drug or device study within 30 days of entering this study;
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699750

Contacts
Contact: Alcon Call Center 1-888-451-3937

Locations
United States, Texas
Contact Alcon Call Center at 1-888-451-3937 for Trial Locations Recruiting
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Jami Kern, PhD Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01699750     History of Changes
Other Study ID Numbers: M-12-043 / ID11-59
Study First Received: October 2, 2012
Last Updated: January 4, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Alcon Research:
contact lenses
contact lens solution
myopia
astigmatism

Additional relevant MeSH terms:
Astigmatism
Myopia
Refractive Errors
Eye Diseases
Contact Lens Solutions
 Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013