Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period
1 other identifier
interventional
112
2 countries
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2007
Shorter than P25 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 26, 2008
CompletedFirst Posted
Study publicly available on registry
September 30, 2008
CompletedResults Posted
Study results publicly available
November 25, 2014
CompletedJune 19, 2018
May 1, 2015
7 months
September 26, 2008
March 28, 2014
June 18, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
Corneal Staining
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.
at 3 months of lens wear (period 1)
Limbal Redness
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.
at 3 months of lens wear (period 1)
Bulbar Redness
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.
at 3 months of lens wear (period 1)
Tarsal Roughness
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.
at 3 months of lens wear (period 1)
Study Arms (3)
senofilcon A toric bilaterally
ACTIVE COMPARATORsenofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
balafilcon A toric bilaterally
ACTIVE COMPARATORbalafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
senofilcon A/balafilcon A contralaterally
ACTIVE COMPARATORsenofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.
Interventions
soft contact lens
soft contact lens
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Boston, Massachusetts, 021115, United States
Unknown Facility
Newtown, New South Wales, 2042, Australia
Unknown Facility
Camberwell, Victoria, 3124, Australia
Unknown Facility
Hawthorn, Victoria, 3122, Australia
Unknown Facility
Keilor, Victoria, 3036, Australia
Unknown Facility
Melbourne, Victoria, 3000, Australia
Unknown Facility
Mitcham, Victoria, 3132, Australia
Unknown Facility
Yallourn, Victoria, 3825, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Buch, OD
- Organization
- Johnson & Johnson Vision Care, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2008
First Posted
September 30, 2008
Study Start
June 1, 2007
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
June 19, 2018
Results First Posted
November 25, 2014
Record last verified: 2015-05