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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01699750
First received: October 2, 2012
Last updated: December 3, 2014
Last verified: December 2014
  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.


Condition Intervention
Myopia
Astigmatism
Refractive Error
Device: Lotrafilcon B contact lenses
Device: Senofilcon A contact lenses
Device: OPTI-FREE® PUREMOIST® MPDS
Device: BIOTRUE®
Device: Balafilcon A contact lenses
Device: ReNu® Multiplus®

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel 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:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Ex-Vivo Total Lipid Uptake Per Lens [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean.


Secondary Outcome Measures:
  • Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT) [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    The pre-lens tear film is the layer of tears located on top of the contact lens between the eyelid and the contact lens. NIBUT (i.e., the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film) was measured using a diffuse illumination source (Tearscope) and videotography. A longer NIBUT indicates a more stable tear film and greater on-eye lens wettability. One eye (study eye) contributed to the mean.

  • LogMAR Time-Controlled Visual Acuity (TCVA) [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    Visual performance was measured binocularly (both eyes together) at two contrast levels using a validated Time Controlled Visual Acuity test (TCVA). TCVA was recorded in VA units (1 VA unit=1 VA line=0.1 logMAR), with positive (+) values corresponding with VA better than 20/20 and negative (-) values worse than 20/20.

  • Overall Comfort Measured With Visual Analog Scale (VAS) [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    The participant rated overall comfort on a 100-millimeter analog scale by marking a line that best corresponds to their eye comfort (0=very poor, 100=excellent). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.

  • Overall Dryness Measured With Visual Analog Scale (VAS) [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    The participant rated overall dryness on a 100-millimeter analog scale by marking a line that best describes how dry their eyes feel (0=not at all dry, 100=very dry). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.

  • Average Exposure Speed [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    Exposure speed (rate of increase in exposed lens surface % (areas not protected by tear film) after the first tear film break and before the second blink) was measured with a diffuse illumination source (Tearscope) and videotography. Higher speeds indicate worse tear film dynamics. One eye (study eye) contributed to the mean.

  • Minimum Protected Area [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    Minimum protected area (i.e., minimum area of the lens (%) covered by the tear film during the interblink period) was measured using a diffuse illumination source (Tearscope) and videotography. A higher value indicates a larger area of the tearfilm spread evenly over the lens (i.e., less area of tear film breakage). One eye (study eye) contributed to the mean.


Enrollment: 109
Study Start Date: December 2012
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
Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
Device: Lotrafilcon B contact lenses
Silicone hydrogel contact lenses, Phase 2
Other Names:
  • AIR OPTIX® AQUA
  • AOA
Device: OPTI-FREE® PUREMOIST® MPDS
Contact lens care system, Phase 2
Other Name: OFPM
Device: BIOTRUE®
Contact lens care system, Phase 2
Device: Balafilcon A contact lenses
Silicone hydrogel contact lenses worn for 30 days, Phase 1
Other Name: PureVision
Device: ReNu® Multiplus®
Contact lens care system used for 30 days, Phase 1
Active Comparator: Acuvue Oasys
Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
Device: Senofilcon A contact lenses
Silicone hydrogel contact lenses, Phase 2
Other Names:
  • ACUVUE® OASYS® with HYDRACLEAR®
  • AVO
Device: OPTI-FREE® PUREMOIST® MPDS
Contact lens care system, Phase 2
Other Name: OFPM
Device: BIOTRUE®
Contact lens care system, Phase 2
Device: Balafilcon A contact lenses
Silicone hydrogel contact lenses worn for 30 days, Phase 1
Other Name: PureVision
Device: ReNu® Multiplus®
Contact lens care system used for 30 days, Phase 1

Detailed Description:

This study will be divided into two phases. In the Pre-Investigational Phase (Phase 1), participants will wear PureVision contact lenses for 30 days and use ReNu® Multiplus® for contact lens care. Eligible participants will continue into the Investigational Phase (Phase 2) and be randomly assigned to wear AIR OPTIX® AQUA contact lenses or ACUVUE® OASYS® with HYDRACLEAR® contact lenses for a total of two months. For contact lens care, participants will use OPTI-FREE® PUREMOIST® MPDS and BIOTRUE® for 30 days each.

  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
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: NCT01699750

Locations
United States, Texas
Contact Alcon Call Center at 1-888-451-3937 for Trial Locations
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
Results First Received: December 1, 2014
Last Updated: December 3, 2014
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 07, 2015