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

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: senofilcon A toric contact lens; Device: balafilcon A toric contact lens

• Registration Number: NCT00762502
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-26
• Study First Posted: 2008-09-30
• Results First Submitted: 2014-03-28
• Results First Submitted QC: 2014-11-18
• Results First Posted: 2014-11-25
• Status Verified: 2015-05
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
senofilcon A/balafilcon A contralaterally	senofilcon A toric contact lens	senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.
senofilcon A toric bilaterally	senofilcon A toric contact lens	senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
balafilcon A toric bilaterally	balafilcon A toric contact lens	balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
senofilcon A/balafilcon A contralaterally	balafilcon A toric contact lens	senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.

Primary Outcome Measures

Name	Time	Method
Corneal Staining	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.
Limbal Redness	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	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	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.