NCT01228591

Brief Summary

The purpose of this study is to compare the performance of the ACUVUE® ADVANCE® Plus lenses against ACUVUE® ADVANCE® lenses in the plus power parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2010

Shorter than P25 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
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2010

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

February 3, 2014

Completed
Last Updated

June 19, 2018

Status Verified

May 1, 2015

Enrollment Period

1 month

First QC Date

October 22, 2010

Results QC Date

September 17, 2013

Last Update Submit

June 18, 2018

Conditions

Hyperopia

Outcome Measures

Primary Outcomes (2)

  • Visual Acuity One Week After Lens Wear

    Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected.

    1 week

  • Visual Acuity at Time of Initial Fit

    Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study.

    After 10-15 minutes of lens wear

Secondary Outcomes (4)

  • Contact Lens Comfort Using Contact Lens User Experience (CLUE)

    1 week

  • Subject Reported Vision Using Contact Lens User Experience (CLUE).

    1 week

  • Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE)

    Baseline

  • Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE)

    Baseline

Study Arms (2)

Acuvue Advance Plus/ Acuvue Advance

OTHER

Acuvue Advance Plus contact lenses worn first period and Acuvue Advance contact lenses worn second.

Device: Acuvue Advance PlusDevice: Acuvue Advance

Acuvue Advance/Acuvue Advance Plus

OTHER

Acuvue Advance contact lenses worn first period and Acuvue Advance Plus contact lenses worn second.

Device: Acuvue Advance PlusDevice: Acuvue Advance

Interventions

Acuvue Advance PlusDEVICE

Silicone hydrogel contact lens.

Acuvue Advance Plus/ Acuvue AdvanceAcuvue Advance/Acuvue Advance Plus
Acuvue AdvanceDEVICE

Silicone hydrogel contact lens

Acuvue Advance Plus/ Acuvue AdvanceAcuvue Advance/Acuvue Advance Plus

Eligibility Criteria

Age18 Years - 45 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 45 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 (defined as a minimum of 6 hours with a minimum of at least 1 month's wear prior to the study).
  • The subject's optimal verified spherical equivalent distance correction must be between +1.00 and + 6.00D.
  • 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 the 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, bifocal, in monovision contact lens wear, or is worn as extended wear.
  • Need any near correction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Winter Park, Florida, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Nanticoke, Pennsylvania, United States

Location

MeSH Terms

Conditions

Hyperopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Brian Pall, O.D., M.S., F.A.A.O. Principal Research Optometrist
Organization
Johnson & Johnson Vision Care
bpall@its.jnj.com
1 904 443-1290

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2010

First Posted

October 26, 2010

Study Start

October 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

June 19, 2018

Results First Posted

February 3, 2014

Record last verified: 2015-05

Locations

US(3)