Clinical Comparison of Two Silicone-Hydrogel Contact Lenses

Johnson & Johnson (J&J)

Status: Completed

Conditions: Refractive Error

Treatments: Device: comfilcon A; Device: galyfilcon A

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00762385

CR-0713

Details and patient eligibility

About

The objective of this study is to evaluate the clinical performance of two silicone-hydrogel contact lenses.

Enrollment: 97 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject must be at least 18 and less than or equal to 39 years of age and have a need for vision correction in both eyes.
• The subject must require a lens power between -1.00 to -6.00D and have no more than 1.00D of corneal cylinder.
• The subject, based on his/her knowledge, must be in good general health.
• The subject must be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluations.
• Subject must be a current adapted daily wearer of soft contact lenses with at least 6 months of CL wear.
• Subject must agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
• Subject must be willing and able to use only the care systems and lubricating drops provided for the study during the 4 week period.
• The subject must read, indicate understanding of and sign the Informed Consent Form.

Exclusion criteria

• The subject is a rigid gas permeable (RGP) or daily disposable lens wearer.

• The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids or associated structures.

• The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjogren's syndrome, type II diabetes, etc.)

• Slit lamp findings that would contraindicate contact lens wear such as:

  • pathological dry eye or associated findings
  • pterygium or corneal scars within the visual axis
  • neovascularization equal to or greater than 1mm in from the limbus
  • history of giant papillary conjunctivitis (GPC) worse than grade 2
  • anterior uveitis or iritis (past or present)
  • seborrhoeic eczema
  • seborrhoeic conjunctivitis

• A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.

• A known history of corneal hypoesthesia (reduced corneal sensitivity).

• Contact lens snellen visual acuities (VA) worse than 20/30.

• Aphakia, keratoconus or a highly irregular cornea.

• Current pregnancy or lactation (to the best of the subject's knowledge)

• Any active participation in another clinical study at any time during this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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97 participants in 2 patient groups

galyfilcon A/comfilcon A

Active Comparator group

Description:

galyfilcon A first, comfilcon A second

Treatment:

Device: galyfilcon A

Device: comfilcon A

comfilcon A/galyfilcon A

Active Comparator group

Description:

comfilcon A first, galyfilcon A second

Treatment:

Device: galyfilcon A

Device: comfilcon A