Study of ACUVUE® ADVANCE® PLUS Contact Lenses.

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244893
• Other study ID #: CR-1636BI
• Status: Completed
• Phase: N/A
• Start date: October 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 this study is to compare ACUVUE® ADVANCE® Plus contact lenses made prior to process qualification (prePQ) against the ACUVUE® ADVANCE® Plus lenses made after the process qualification (postPQ).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• The subject must be at least 18 years of age and no more than 39 years of age.

• 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 (minimum of 6 hours per day).

• 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:
• Acuvue Advance Plus prePQ
silicone hydrogel contact lens manufactured prior to equipment process qualification activities.
• Acuvue Advance Plus postPQ
silicone hydrogel contact lens manufactured after equipment process qualification activities.

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	Visual Acuity (VA)	Snellen VA was measured to the nearest letter then converted to the logMAR scale for the analysis. Values < 0 imply a clinically positive result; while values > 0 infer a clinically negative result.	6-8 days after lens wear
Secondary	Corneal Staining	Corneal staining type was assessed by Investigator using a slit lamp and graded on a 5-point scale; 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.	6-8 days after lens wear
Secondary	Limbal Redness	Limbal redness was assessed by using a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.	6-8 days after lens wear
Secondary	Bulbar Redness	Scale of 0 increasing to 4. 0=None, 4=Severe Redness	6-8 days after lens wear