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Clinical Performance Comparison of Two Contact Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00975585
Recruitment Status : Completed
First Posted : September 11, 2009
Results First Posted : March 22, 2011
Last Update Posted : June 19, 2018
Sponsor:
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Study Description
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Brief Summary:
The purpose of this study is to compare the clinical performance of two contact lenses.

Condition or disease Intervention/treatment Phase
Myopia Device: senofilcon A Device: lotrafilcon B Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 379 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Two Silicone Hydrogel Frequent Replacement Contact Lenses
Actual Study Start Date : August 1, 2009
Actual Primary Completion Date : October 1, 2009
Actual Study Completion Date : October 1, 2009

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Average Corneal Staining [ Time Frame: 2 weeks ]
    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.

  2. Visual Acuity [ Time Frame: 2 weeks ]
    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.

  3. Overall Comfort [ Time Frame: 2 weeks ]
    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.

  4. Overall Comfort [ Time Frame: 2 weeks and 4 weeks ]
    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 :
  1. Limbal Redness [ Time Frame: 2 weeks ]
    The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe

  2. Bulbar Redness [ Time Frame: 2 weeks ]
    The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe

  3. Symptoms of Dryness [ Time Frame: 2 weeks ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975585


Locations
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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
Johnson & Johnson Vision Care, Inc.
Visioncare Research Ltd.
Investigators
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Study Director: Sheila, B Hickson-Curran, BSc, MCOptom Johnson & Johnson Vision Care, Inc.
More Information
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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00975585    
Other Study ID Numbers: CR-0907
PHNX-518
First Posted: September 11, 2009    Key Record Dates
Results First Posted: March 22, 2011
Last Update Posted: June 19, 2018
Last Verified: August 2017
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases