Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period

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 Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: senofilcon A toric contact lens; Device: balafilcon A toric contact lens

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Newtown, New South Wales, Australia, 2042
  • Victoria
    • Camberwell, Victoria, Australia, 3124
    • Hawthorn, Victoria, Australia, 3122
    • Keilor, Victoria, Australia, 3036
    • Melbourne, Victoria, Australia, 3000
    • Mitcham, Victoria, Australia, 3132
    • Moe, Victoria, Australia, 3825
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 021115

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: senofilcon A toric bilaterally; senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.	Device: senofilcon A toric contact lens; soft contact lens
Active Comparator: balafilcon A toric bilaterally; balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.	Device: balafilcon A toric contact lens; soft contact lens
Active Comparator: 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.	Device: senofilcon A toric contact lens; soft contact lens; Device: balafilcon A toric contact lens; soft contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: September 26, 2008
• First Submitted That Met QC Criteria: September 26, 2008
• First Posted (Estimate): September 30, 2008

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: CR-4498