Skip to main content
OpenTrials
Completed

NCT Number: NCT01244893

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Powell, Ohio, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acuvue Advance Plus prePQ

Device

silicone hydrogel contact lens manufactured prior to equipment process qualification activities.

Acuvue Advance Plus postPQ

Device

silicone hydrogel contact lens manufactured after equipment process qualification activities.

Primary outcomes

  1. Visual Acuity (VA)

    Time frame: 6-8 days after lens wear

    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.

Secondary outcomes

  1. Corneal Staining

    Time frame: 6-8 days after lens wear

    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.

  2. Limbal Redness

    Time frame: 6-8 days after lens wear

    Limbal redness was assessed by using a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.

  3. Bulbar Redness

    Time frame: 6-8 days after lens wear

    Scale of 0 increasing to 4. 0=None, 4=Severe Redness

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
First posted
Nov 19, 2010
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.