Clinical trial NCT00912028: Clinical Performance Comparison of Several Different Contact Lenses
Official title: Multicenter, Single-masked, Randomized, Parallel, Controlled Study to Compare Senofilcon A Contact Lenses to Currently Used Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Limbal Hyperemia (Redness)
timeFrame: 2 weeks
measure: Limbal Hyperemia (Redness)
timeFrame: 4 weeks
measure: Bulbar Hyperemia (Redness)
timeFrame: 2 weeks
measure: Bulbar Hyperemia (Redness)
timeFrame: 4 weeks
measure: Corneal Staining
timeFrame: 2 weeks
measure: Corneal Staining
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Salvador
country: Brazil
state: BA
city: Recife
country: Brazil
state: PE
city: Maringá
country: Brazil
state: PR
city: Rio de Janeiro
country: Brazil
state: RJ
city: Campinas
country: Brazil
state: SP
city: Marilia
country: Brazil
state: SP
city: Ribeirão Preto
country: Brazil
state: SP
city: Santo André
country: Brazil
state: SP
city: São Paulo
country: Brazil
state: SP
city: São Paulo
country: Brazil
state: SP
city: São Paulo
country: Brazil
state: SP
Study officials:
affiliation: Associate Professor - Ophthalmolgy, University of Campinas, Brazil
name: Carlos E Leite Arieta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: