Clinical Performance Comparison of Two Contact Lenses
- Conditions
- Myopia
- Interventions
- Device: senofilcon ADevice: lotrafilcon B
- Registration Number
- NCT00975585
- Lead Sponsor
- Johnson & Johnson Vision Care, Inc.
- Brief Summary
The purpose of this study is to compare the clinical performance of two contact lenses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 379
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description senofilcon A both eyes senofilcon A soft contact lens worn daily for 2 weeks, with a 2-week replacement regimen. lotrafilcon B both eyes lotrafilcon B soft contact lens worn daily for 4 weeks, with a 4-week replacement regimen
- Primary Outcome Measures
Name Time Method Average Corneal Staining 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 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 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
Name Time Method Limbal Redness 2 weeks The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Bulbar Redness 2 weeks The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Symptoms of Dryness 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