N/A
N=379
Clinical Performance Comparison of Two Contact Lenses
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT00975585 ↗Enrolled (actual)
379
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Average Corneal Staining — 0.157; 0.170 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- senofilcon A (Device); lotrafilcon B (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Corneal Staining |
0.157; 0.170 | — |
| PRIMARY Visual Acuity |
-0.012; -0.002 | — |
| PRIMARY Overall Comfort |
3.534; 3.436 | — |
| PRIMARY Overall Comfort |
3.534; 3.436 | — |
| SECONDARY Limbal Redness |
0.376; 0.499 | — |
| SECONDARY Bulbar Redness |
0.465; 0.532 | — |
| SECONDARY Symptoms of Dryness |
2.003; 2.414 | — |
Summary
The purpose of this study is to compare the clinical performance of two contact lenses.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00975585). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.