Vistakon Investigational Lens Worn as a Single Use Daily Wear

Johnson & Johnson (J&J)

Status: Completed

Conditions: Myopia

Treatments: Device: narafilcon B; Device: etafilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01031004

CR-1655

Details and patient eligibility

About

This study is intended to show that the investigational contact lens is clinically equivalent to a currently approved contact lens, when worn as single-use on a daily basis.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• eyes must be best-corrected to a visual acuity of 20/30 or better in each eye
• must be able and willing to wear soft contact lenses on a single use, daily wear basis for the duration of the study
• distance spherical contact lens prescription must be within the range available for the study

Exclusion criteria

• systemic diseases which may interfere with contact lens wear
• ocular infection or clinically significant ocular disease
• any previous intraocular surgery
• grade 2 or greater slit lamp findings
• currently pregnant or lactating
• more than 1.00D of refractive astigmatism in either eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

narafilcon B

Experimental group

Description:

contact lens

Treatment:

Device: narafilcon B

etafilcon A

Active Comparator group

Description:

contact lens

Treatment:

Device: etafilcon A