Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses

Johnson & Johnson (J&J)

Status: Completed

Conditions: Myopia

Treatments: Device: lotrafilcon B, BC 8.60; Device: comfilcon A, BC 8.60; Device: galyfilcon A, BC 8.30

Study type: Interventional

Funder types: Industry

Identifiers

NCT01244516

CR-201007

Details and patient eligibility

About

The purpose of this study is to compare the clinical performance of three silicone hydrogel contact lenses over a 2 week period.

Enrollment: 540 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be no less than 18 and no more than 39 years of age.
• Sign Written Informed Consent and investigator to record this on Case Report Form.
• Be willing and able to adhere to the instructions set out in the protocol.
• Be an existing successful daily wear soft contact lens wearer. For the purposes of this study this means wearing lenses for at least 6 hours per day, 5 days per week for the last month.
• No extended wear in the last 3 months.
• Subjective refraction must result in a vertex corrected spherical contact lens prescription between -1.00 and -6.00 diopters.
• Have refractive astigmatism less than or equal to 1.00 diopters (D) in both eyes.
• Achieve visual acuity of 6/9 (20/30) or better in each eye.
• Require a visual correction in both eyes (no monovision allowed).
• Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: no amblyopia, no evidence of lid abnormality or infection (including blepharitis/meibomitis), no conjunctival abnormality or infection, no clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities), no other active ocular disease.

Exclusion criteria

• Requires concurrent ocular medication.
• Clinically significant corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
• Clinically significant corneal staining
• Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00 diopters).
• Has had refractive surgery.
• Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
• Abnormal lacrimal secretions.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Keratoconus or other corneal irregularity.
• Hard, hybrid or Rigid Gas Permeable lens wear in the previous 8 weeks.
• Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
• Diabetic.
• Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease [e.g., Human immunodeficiency virus (HIV)].
• History of chronic eye disease (e.g. glaucoma or Age Related Macular Degeneration).
• Pregnancy, lactating or planning a pregnancy at the time of enrollment.
• Participation in any concurrent clinical trial or in last 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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540 participants in 3 patient groups

galyfilcon A

Other group

Description:

Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.

Treatment:

Device: galyfilcon A, BC 8.30

lotrafilcon B

Other group

Description:

Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.

Treatment:

Device: lotrafilcon B, BC 8.60

comfilcon A

Other group

Description:

Subjects that were randomized to wear comfilcon A lens throughout the course of the study.

Treatment:

Device: comfilcon A, BC 8.60