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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

September 10, 2009
August 16, 2013
August 2009
October 2009   (final data collection date for primary outcome measure)
  • 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.
  • corneal staining [ Time Frame: every 2 weeks ] [ Designated as safety issue: No ]
  • subjective comfort ratings [ Time Frame: every 2 weeks ] [ Designated as safety issue: No ]
  • visual acuity [ Time Frame: every 2 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00975585 on ClinicalTrials.gov Archive Site
  • 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
limbal and bulbar redness [ Time Frame: every 2 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Clinical Performance Comparison of Two Contact Lenses
Clinical Evaluation of Two Silicone Hydrogel Frequent Replacement Contact Lenses

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Myopia
  • Device: senofilcon A
    soft contact lens, 2-week replacement indicated
  • Device: lotrafilcon B
    soft contact lens with a 4-week replacement indicated.
  • Active Comparator: senofilcon A both eyes
    soft contact lens worn daily for 2 weeks, with a 2-week replacement regimen.
    Intervention: Device: senofilcon A
  • Active Comparator: lotrafilcon B both eyes
    soft contact lens worn daily for 4 weeks, with a 4-week replacement regimen
    Intervention: Device: lotrafilcon B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
379
Not Provided
October 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00975585
CR-0907, PHNX-518
No
Vistakon
Vistakon
Visioncare Research Ltd.
Study Director: Sheila , B Hickson-Curran, BSc, MCOptom Vistakon
Vistakon
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP