Study of ACUVUE® ADVANCE® PLUS Contact Lenses.

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).

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Acuvue Advance Plus prePQ; Device: Acuvue Advance Plus postPQ

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Powell, Ohio, United States
  • Rhode Island
    • Warwick, Rhode Island, United States
  • Virginia
    • Salem, Virginia, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Acuvue Advance Plus prePQ/Acuvue Advance Plus postPQ; Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to process qualification will be worn first and Acuvue AdvancePlus silicone hydrogel contact lens manufactured after process qualification will be worn second.	Device: Acuvue Advance Plus prePQ; silicone hydrogel contact lens manufactured prior to equipment process qualification activities.; Device: Acuvue Advance Plus postPQ; silicone hydrogel contact lens manufactured after equipment process qualification activities.
Other: Acuvue Advance Plus postPQ/Acuvue Advance Plus prePQ; Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to process qualification worn first and Acuvue Advance Plus silicone hydrogel contact lens manufactured after process qualification worn second.	Device: Acuvue Advance Plus prePQ; silicone hydrogel contact lens manufactured prior to equipment process qualification activities.; Device: Acuvue Advance Plus postPQ; silicone hydrogel contact lens manufactured after equipment process qualification activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Bulbar Redness	Scale of 0 increasing to 4. 0=None, 4=Severe Redness	6-8 days after lens wear

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: November 18, 2010
• First Submitted That Met QC Criteria: November 18, 2010
• First Posted (Estimate): November 19, 2010

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CR-1636BI