Clinical Performance Comparison of Several Different Contact Lenses

N/ACompletedNCT00912028

Johnson & Johnson Vision Care, Inc.71 enrolled

Overview

The purpose of the study is to evaluate the possible benefits of second generation silicone hydrogel contact lenses.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Myopia

Interventions

senofilcon ADEVICE

contact lens

lotrafilcon BDEVICE

contact lens

balafilcon ADEVICE

contact lens

methafilcon A

Eligibility

Sex: ALLMin age: 18 YearsMax age: 39 Years

Medical Language ↔ Plain English

Inclusion Criteria: Subjects must: * be existing soft contact lens wearers of the study control lenses * require a distance visual correction in both eyes * have a contact lens spherical distance requirement between -1.00 diopters (D) and -8.00D in both eyes * have astigmatism less than or equal to 1.00D in both eyes * be able to wear lenses available for this study * be corrected to a visual acuity of 6/9 (20/30) or better in each eye * have normal eyes with no evidence of abnormality or disease Exclusion Criteria: Subject are excluded for the following reasons: * monovision corrected * worn lenses extended wear in the last 3 months. * require concurrent ocular medication * grade 3 or 4 abnormalities * grade 3 corneal staining in more than two regions * anterior ocular surgery * any other ocular surgery or injury within 8 weeks prior to study enrollment * abnormal lachrymal secretions * pre-existing ocular irritation that would preclude contact lens fitting * corneal irregularities * Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in past 12 weeks * any systemic illness which would preclude contact lens wear * diabetes * infectious or immunosuppressive disease * pregnancy or lactating, or planning pregnancy at time or enrollment * participating in a concurrent clinical study or within last 60 days * allergy to the standardized study care solution

Locations (11)

Unnamed facility

Salvador, Estado de Bahia, Brazil

Unnamed facility

Maringá, Paraná, Brazil

Unnamed facility

Recife, Pernambuco, Brazil

Unnamed facility

Rio de Janeiro, Rio de Janeiro, Brazil

Outcomes

Primary Outcomes

Limbal Hyperemia (Redness)

Subject distribution according to limbal hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.

Time frame: 2 weeks

Limbal Hyperemia (Redness)

Subject distribution according to limbal hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.

Time frame: 4 weeks

Bulbar Hyperemia (Redness)

Subject distribution according to bulbar hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.

Time frame: 2 weeks

Bulbar Hyperemia (Redness)

Subject distribution according to bulbar hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.

Time frame: 4 weeks

Corneal Staining

Subject distribution according to corneal staining with fluorescein scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.

Time frame: 2 weeks

Corneal Staining

Subject distribution according to corneal staining with fluorescein scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.

Time frame: 4 weeks

Data from ClinicalTrials.gov

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