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

Johnson & Johnson Vision Care, Inc.112 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

112

Conditions

Astigmatism

Interventions

senofilcon A toric contact lensDEVICE

soft contact lens

balafilcon A toric contact lensDEVICE

soft contact lens

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (8)

Unnamed facility

Boston, Massachusetts, United States

Unnamed facility

Newtown, New South Wales, Australia

Unnamed facility

Camberwell, Victoria, Australia

Unnamed facility

Hawthorn, Victoria, Australia

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: at 3 months of lens wear (period 1)

Data from ClinicalTrials.gov

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