Pilot Evaluation of a New Galyfilcon A Lens Prototype and Enfilcon A Lens

Myopia Clinical Trial

Official title:

Dispensing Evaluation of a New Galyfilcon A Prototype and Avaira Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192542
• Other study ID #: CR-1636BE
• Status: Completed
• Phase: N/A
• Start date: August 2010

Study information

• Verified date: May 2016
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the visual acuity, limbal and bulbar redness of the new galyfilcon A prototype lenses against Avaira® lenses when worn as daily wear for seven (7) days.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study.

• The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.

• Any cylinder power must be = -0.75D.

• The subject must have visual acuity best correctable to 20/25+3 or better for each eye.

• The subject must read and sign the Statement of Informed Consent.

• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

• Ocular or systemic allergies or disease which might interfere with contact lens wear.

• Systemic disease or use of medication which might interfere with contact lens wear.

• Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.

• Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.

• Any ocular infection.

• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

• Pregnancy or lactation.

• Diabetes.

• Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).

• Habitual contact lens type is toric, multifocal, or is worn as extended wear.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• galyfilcon A prototype lens
Prototype silicone hydrogel contact lens
• enfilcon A lens
Marketed silicone hydrogel 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

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monocular Visual Acuity Assessment	Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale.	Post lens insertion (baseline)
Primary	Binocular Visual Acuity	Snellen binocular visual acuity assessed by the Investigator and was converted to the LogMAR scale. A value <0 implies clinically positive results, a value >0 implies clinically negative results	Post lens insertion (baseline)
Secondary	Limbal Redness of Grade 3 or Above	Limbal redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with limbal redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting.	After 6-8 days of lens wear
Secondary	Bulbar Redness of Grade 3 or Above	Bulbar redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with bulbar redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting.	After 6-8 days of lens wear