NCT01192542

Brief Summary

The purpose of this study is to compare the visual acuity, limbal and bulbar redness of the new galyfilcon A prototype lenses against Avaira® lenses when worn as daily wear for seven (7) days.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
39

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

August 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

January 17, 2014

Completed
Last Updated

June 19, 2018

Status Verified

May 1, 2016

Enrollment Period

1 month

First QC Date

August 30, 2010

Results QC Date

September 17, 2013

Last Update Submit

June 18, 2018

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

  • Monocular Visual Acuity Assessment

    Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale.

    Post lens insertion (baseline)

  • Binocular Visual Acuity

    Snellen binocular visual acuity assessed by the Investigator and was converted to the LogMAR scale. A value \<0 implies clinically positive results, a value \>0 implies clinically negative results

    Post lens insertion (baseline)

Secondary Outcomes (2)

  • Limbal Redness of Grade 3 or Above

    After 6-8 days of lens wear

  • Bulbar Redness of Grade 3 or Above

    After 6-8 days of lens wear

Study Arms (2)

galyfilcon A prototype lens/enfilcon A lens

OTHER

galyfilcon A prototype contact lens worn daily for 6-8 days first then enfilcon A contact lens worn daily for 6-8 days second.

Device: galyfilcon A prototype lensDevice: enfilcon A lens

enfilcon A lens/galyfilcon A prototype lens

OTHER

enfilcon A contact lens worn daily for 6-8 days first then galyfilcon A prototype contact lens worn daily for 6-8 days second.

Device: galyfilcon A prototype lensDevice: enfilcon A lens

Interventions

galyfilcon A prototype lensDEVICE

Prototype silicone hydrogel contact lens

enfilcon A lens/galyfilcon A prototype lensgalyfilcon A prototype lens/enfilcon A lens
enfilcon A lensDEVICE

Marketed silicone hydrogel contact lens

Also known as: Avaira® contact lens
enfilcon A lens/galyfilcon A prototype lensgalyfilcon A prototype lens/enfilcon A lens

Eligibility Criteria

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

You may qualify if:

  • 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.
  • 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

Pismo Beach, California, United States

Location

Unknown Facility

Warwick, Rhode Island, United States

Location

Unknown Facility

Fincastle, 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. Principal Research Optometrist
Organization
Johnson and Johnson Vision Care
bpall@its.jnj.com
1 904 443-1290

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

August 30, 2010

First Posted

September 1, 2010

Study Start

August 1, 2010

Primary Completion

September 1, 2010

Last Updated

June 19, 2018

Results First Posted

January 17, 2014

Record last verified: 2016-05

Locations

US(3)