Trial record 1 of 1 for:    NCT00975585
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Clinical Performance Comparison of Two Contact Lenses

This study has been completed.
Sponsor:
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00975585
First received: September 10, 2009
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to compare the clinical performance of two contact lenses.


Condition Intervention
Myopia
Device: senofilcon A
Device: lotrafilcon B

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

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Average Corneal Staining [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe.

  • Visual Acuity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Visual acuity was assessed by the investigator using the Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR). logMAR ideal is 0.0 and represents 20/20 Snellen visual acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.

  • Overall Comfort [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    After two weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (senofilcon A and lotrafilcon B) using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

  • Overall Comfort [ Time Frame: 2 weeks and 4 weeks ] [ Designated as safety issue: No ]
    After four weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (lotrafilcon B)using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.


Secondary Outcome Measures:
  • Limbal Redness [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe

  • Bulbar Redness [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe

  • Symptoms of Dryness [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Subjects responded to a phone survey question regarding the frequency of the sensation of dryness while wearing the study contact lenses using the following scale: 1=Extreme, 2=Moderate, 3=Slight, 4=None


Enrollment: 379
Study Start Date: August 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: senofilcon A both eyes
soft contact lens worn daily for 2 weeks, with a 2-week replacement regimen.
Device: senofilcon A
soft contact lens, 2-week replacement indicated
Active Comparator: lotrafilcon B both eyes
soft contact lens worn daily for 4 weeks, with a 4-week replacement regimen
Device: lotrafilcon B
soft contact lens with a 4-week replacement indicated.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Existing daily soft lens wearer.
  • Require a distance visual correction in both eyes.
  • Have a contact lens spherical distance refraction between -1.00D and -6.00D.
  • Have refractive astigmatism less than or equal to 1.00D in both eyes.
  • Achieve 20/30 or better corrected distance acuity.
  • Have normal eyes with no evidence of abnormality or disease.

Exclusion Criteria:

  • Requires presbyopic correction.
  • Requires ocular medications.
  • Grade 3 or 4 ocular abnormalities.
  • Grade 3 corneal staining in more than one region.
  • Has had refractive surgery.
  • Any other injury or ocular surgery within 8 weeks prior to study enrollment.
  • Has abnormal lacrimal secretions.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Has keratoconus or other corneal irregularity.
  • Polymethyl methacrylate (PMMA), Hybrid or Rigid Gas Permeable (RGP) wear in the previous 8 weeks.
  • Wears habitual contact lenses that are toric, multifocal or worn extended wear.
  • Any systemic illness which would contraindicate lens wear or the medical treatment of would affect vision or successful lens wear.
  • Diabetic.
  • Infectious or immunosuppressive disease.
  • History of chronic eye disease (e.g glaucoma or age related macular degeneration).
  • Pregnancy, lactation or planning pregnancy at time of enrollment.
  • Participation in any concurrent clinical trial or in another trial in the last 30 days.
  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: NCT00975585

  Hide Study Locations
Locations
United States, Arkansas
North Little Rock, Arkansas, United States, 72116
United States, California
Campbell, California, United States, 95008
United States, Colorado
Colorado Springs, Colorado, United States, 80909
United States, Florida
Jacksonville, Florida, United States, 32205
Jacksonville, Florida, United States, 32256
Miami, Florida, United States, 33155
Winter Park, Florida, United States, 32792
United States, Georgia
Roswell, Georgia, United States, 30076
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Cambridge, Massachusetts, United States, 02140
United States, Missouri
Blue Springs, Missouri, United States, 64015
United States, New York
New York, New York, United States, 10001
United States, Ohio
Chagrin Falls, Ohio, United States, 44023
North Olmsted, Ohio, United States, 44070
Warren, Ohio, United States, 44484
United States, Pennsylvania
State College, Pennsylvania, United States, 16801
United States, Rhode Island
Warwick, Rhode Island, United States, 02888
United States, South Dakota
Chamberlain, South Dakota, United States, 57325
Hot Springs, South Dakota, United States, 57747
United States, Tennessee
Bartlett, Tennessee, United States, 38134
Brentwood, Tennessee, United States, 37027
Memphis, Tennessee, United States, 38119
United States, Texas
Tyler, Texas, United States, 757703
United States, Vermont
Burlington, Vermont, United States, 05401
United States, Wisconsin
West Allis, Wisconsin, United States, 53227
Sponsors and Collaborators
Vistakon
Visioncare Research Ltd.
Investigators
Study Director: Sheila , B Hickson-Curran, BSc, MCOptom Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00975585     History of Changes
Other Study ID Numbers: CR-0907, PHNX-518
Study First Received: September 10, 2009
Results First Received: February 18, 2011
Last Updated: August 16, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 16, 2014