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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Astigmatism

Treatments: Device: balafilcon A toric contact lens; Device: senofilcon A toric contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT00762502

CR-4498

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 3 patient groups

senofilcon A toric bilaterally

Active Comparator group

Description:

senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.

Treatment:

Device: senofilcon A toric contact lens

balafilcon A toric bilaterally

Active Comparator group

Description:

balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.

Treatment:

Device: balafilcon A toric contact lens

senofilcon A/balafilcon A contralaterally

Active Comparator group

Description:

senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.

Treatment:

Device: balafilcon A toric contact lens

Device: senofilcon A toric contact lens