Clinical Performance Comparison of Several Different Contact Lenses

Myopia Clinical Trial

Official title:

Multicenter, Single-masked, Randomized, Parallel, Controlled Study to Compare Senofilcon A Contact Lenses to Currently Used Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00912028
• Other study ID #: AOH--BRA-001
• Status: Completed
• Phase: N/A
• Start date: May 1, 2009
• Est. completion date: February 1, 2010

Study information

• Verified date: August 2017
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 1, 2010
• Est. primary completion date: February 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• senofilcon A
contact lens
• lotrafilcon B
contact lens
• balafilcon A
contact lens
• methafilcon A
contact lens
• vifilcon A
contact lens

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks
Primary	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.	4 weeks
Primary	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.	2 weeks
Primary	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.	4 weeks
Primary	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.	2 weeks
Primary	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.	4 weeks