Status:
COMPLETED
Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Astigmatism
Eligibility:
All Genders
18-45 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00762502
Start Date
June 1 2007
End Date
January 1 2008
Last Update
June 19 2018
Active Locations (8)
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1
Boston, Massachusetts, United States, 021115
2
Newtown, New South Wales, Australia, 2042
3
Camberwell, Victoria, Australia, 3124
4
Hawthorn, Victoria, Australia, 3122