Clinical Performance Comparison of Two Contact Lenses

Johnson & Johnson (J&J)

Status: Completed

Conditions: Myopia

Treatments: Device: senofilcon A; Device: lotrafilcon B

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00975585

CR-0907

PHNX-518

Details and patient eligibility

About

The purpose of this study is to compare the clinical performance of two contact lenses.

Enrollment: 379 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Existing daily soft lens wearer.
• Require a distance visual correction in both eyes.
• Have a contact lens spherical distance refraction between -1.00D and -6.00D.
• Have refractive astigmatism less than or equal to 1.00D in both eyes.
• Achieve 20/30 or better corrected distance acuity.
• Have normal eyes with no evidence of abnormality or disease.

Exclusion criteria

• Requires presbyopic correction.
• Requires ocular medications.
• Grade 3 or 4 ocular abnormalities.
• Grade 3 corneal staining in more than one region.
• Has had refractive surgery.
• Any other injury or ocular surgery within 8 weeks prior to study enrollment.
• Has abnormal lacrimal secretions.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Has keratoconus or other corneal irregularity.
• Polymethyl methacrylate (PMMA), Hybrid or Rigid Gas Permeable (RGP) wear in the previous 8 weeks.
• Wears habitual contact lenses that are toric, multifocal or worn extended wear.
• Any systemic illness which would contraindicate lens wear or the medical treatment of would affect vision or successful lens wear.
• Diabetic.
• Infectious or immunosuppressive disease.
• History of chronic eye disease (e.g glaucoma or age related macular degeneration).
• Pregnancy, lactation or planning pregnancy at time of enrollment.
• Participation in any concurrent clinical trial or in another trial in the last 30 days.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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379 participants in 2 patient groups

senofilcon A both eyes

Active Comparator group

Description:

soft contact lens worn daily for 2 weeks, with a 2-week replacement regimen.

Treatment:

Device: senofilcon A

lotrafilcon B both eyes

Active Comparator group

Description:

soft contact lens worn daily for 4 weeks, with a 4-week replacement regimen

Treatment:

Device: lotrafilcon B