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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00975585
First Posted: September 11, 2009
Last Update Posted: September 28, 2017
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.
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
  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 (Participant)
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 Johnson & Johnson Vision Care, Inc.:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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:
  • 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

  • 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

  • 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


Enrollment: 379
Actual Study Start Date: August 1, 2009
Study Completion Date: October 1, 2009
Primary Completion Date: October 1, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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


  Show 25 Study Locations
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
Visioncare Research Ltd.
Investigators
Study Director: Sheila , B Hickson-Curran, BSc, MCOptom Johnson & Johnson Vision Care, Inc.
  More Information

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00975585     History of Changes
Other Study ID Numbers: CR-0907
PHNX-518
First Submitted: September 10, 2009
First Posted: September 11, 2009
Results First Submitted: February 18, 2011
Results First Posted: March 22, 2011
Last Update Posted: September 28, 2017
Last Verified: August 2017