N/A
N=112
Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period
Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT00762502 ↗Enrolled (actual)
112
Serious AEs
0.6%
Results posted
Nov 2014
Primary outcome: Primary: Corneal Staining — 0.6; 0.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- senofilcon A toric contact lens (Device); balafilcon A toric contact lens (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Corneal Staining |
0.6; 0.8 | — |
| PRIMARY Limbal Redness |
0.7; 0.7 | — |
| PRIMARY Bulbar Redness |
0.9; 0.8 | — |
| PRIMARY Tarsal Roughness |
1.1; 1.0 | — |
Summary
To evaluate two toric contact lenses on the ocular physiology of existing contact lens wearers when used in an extended wear modality of days/six nights.
Eligibility Criteria
Inclusion Criteria
- Able to wear study lenses in parameters available
- Non-presbyopes between the ages of 18-45
- Understand and sign informed consent
- Willing to follow the protocol
- Achieve at least 20/30 (6/9) visual acuity (VA) in right eye (OD) and left eye (OS) with study lenses
- Myopia -0.75 to -6.25, cylinder -0.75 to -1.50 diopters (D) (axis 90 +/- 15, 180 +/- 15) or -1.75 D (axis 90 +/- 10, 180 +/- 10)
- Adapted soft contact lens wearer
- Swims no more than once a week
- Has a wearable pair of spectacles.
Exclusion Criteria
- Any ocular or systemic disorder which may contraindicate contact lens wear
- Any topical ocular medication
- Aphakic
- Corneal refractive surgery
- Corneal distortion from hard CL wear or keratoconus
- Pregnant or lactating
- Grade 2 or worse slit lamp signs
- Infectious disease
- Previous clinical study within 2 weeks
- Don't agree to participate
- Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in last 8 weeks
- Previous adverse effects that contraindicate extended lens wear.
- Self-reported symptoms of itchiness or scratchiness with habitual lenses.
Data sourced from ClinicalTrials.gov (NCT00762502). 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.