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OpenTrials
Completed

NCT Number: NCT00975585

Clinical Performance Comparison of Two Contact Lenses

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Senofilcon A

Device

soft contact lens, 2-week replacement indicated

lotrafilcon B

Device

soft contact lens with a 4-week replacement indicated.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Collaborators

  • Visioncare Research Ltd.

Registry information

Official study title

Clinical Evaluation of Two Silicone Hydrogel Frequent Replacement Contact Lenses

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 11, 2009
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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