Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism

Johnson & Johnson (J&J)

Status: Completed

Conditions: Astigmatism

Treatments: Device: galyfilcon A toric; Device: senofilcon A toric

Study type: Interventional

Funder types: Industry

Identifiers

NCT00697190

CR-4523

Details and patient eligibility

About

This study will evaluate the fitting characteristics and physiological response of two toric lenses manufactured by Vistakon.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to wear study lenses in parameters available.
• At least 18
• understand and sign informed consent
• willing to follow the protocol
• achieve at least 6/9 Visual Acuity (VA), both eyes (OU) with study lenses
• hyperopes: +2.00 to +4.00 with -0.75 D cylinder around 180, high myopes: -6.00 to -8.00 with -1.25 D cylinder around 180
• oblique axis: -2.00 to -4.00 with -0.75 D cyl around 45 or 135, have worn Soft Contact Lenses's within last 6 months

Exclusion criteria

• Any ocular or systemic disorder which may contraindicate Contact Lens (CL) 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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39 participants in 2 patient groups

senofilcon A/galyfilcon A

Active Comparator group

Description:

senofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second.

Treatment:

Device: senofilcon A toric

Device: galyfilcon A toric

galyfilcon A/senofilcon A

Active Comparator group

Description:

galyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second.

Treatment:

Device: senofilcon A toric

Device: galyfilcon A toric