NCT01244893

Brief 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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

February 3, 2014

Completed
Last Updated

June 19, 2018

Status Verified

August 1, 2017

Enrollment Period

1 month

First QC Date

November 18, 2010

Results QC Date

August 29, 2013

Last Update Submit

June 18, 2018

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Corneal Staining

    6-8 days after lens wear

  • Limbal Redness

    6-8 days after lens wear

  • Bulbar Redness

    6-8 days after lens wear

Study Arms (2)

Acuvue Advance Plus prePQ/Acuvue Advance Plus postPQ

OTHER

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 prePQDevice: Acuvue Advance Plus postPQ

Acuvue Advance Plus postPQ/Acuvue Advance Plus prePQ

OTHER

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 prePQDevice: Acuvue Advance Plus postPQ

Interventions

Acuvue Advance Plus prePQDEVICE

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

Acuvue Advance Plus postPQ/Acuvue Advance Plus prePQAcuvue Advance Plus prePQ/Acuvue Advance Plus postPQ
Acuvue Advance Plus postPQDEVICE

silicone hydrogel contact lens manufactured after equipment process qualification activities.

Acuvue Advance Plus postPQ/Acuvue Advance Plus prePQAcuvue Advance Plus prePQ/Acuvue Advance Plus postPQ

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Powell, Ohio, United States

Location

Unknown Facility

Warwick, Rhode Island, United States

Location

Unknown Facility

Salem, Virginia, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Brian Pall, O.D., M.S., F.A.A.O. Senior Research Optometrist
Organization
Johnson & Johnson Vision Care
BPALL@its.jnj.com
(904) 443-1290

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2010

First Posted

November 19, 2010

Study Start

October 1, 2010

Primary Completion

November 1, 2010

Last Updated

June 19, 2018

Results First Posted

February 3, 2014

Record last verified: 2017-08

Locations

US(3)