Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 112
- Locations
- 8
- Primary Endpoint
- Limbal Redness
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
senofilcon A toric bilaterally
senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
Intervention: senofilcon A toric contact lens (Device)
balafilcon A toric bilaterally
balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
Intervention: balafilcon A toric contact lens (Device)
senofilcon A/balafilcon A contralaterally
senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.
Intervention: senofilcon A toric contact lens (Device)
senofilcon A/balafilcon A contralaterally
senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.
Intervention: balafilcon A toric contact lens (Device)
Outcomes
Primary Outcomes
Limbal Redness
Time Frame: at 3 months of lens wear (period 1)
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Corneal Staining
Time Frame: at 3 months of lens wear (period 1)
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Bulbar Redness
Time Frame: at 3 months of lens wear (period 1)
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Tarsal Roughness
Time Frame: at 3 months of lens wear (period 1)
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Secondary Outcomes
No secondary outcomes reported