NCT00241280

Brief Summary

Study in the US intended to evaluate the safety and effectiveness of a Johnson \& Johnson Vision Care Inc, (JJVCI) contact lens for use on an extended-wear basis for up to 7 days (6 nights).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
504

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

25 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

September 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
9.4 years until next milestone

Results Posted

Study results publicly available

February 25, 2016

Completed
Last Updated

March 24, 2016

Status Verified

February 1, 2016

Enrollment Period

1.1 years

First QC Date

October 14, 2005

Results QC Date

December 4, 2015

Last Update Submit

February 24, 2016

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

  • Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40

    Percentage of subject eyes reported with visual acuity worse than 20/40 at each study visit.

    Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks

  • Rate of Contact Lens Related Serious and Significant Events (SSE)

    The number of Contact-Lens related Serious and Significant Adverse Events were reported for each study lens. The incidence of rates of contact-lens related SSEs were calculated as (# of subjects that experienced an event)/(total # subjects). If there were multiple diagnostic findings, the event was categorized under the highest event level diagnostic.

    Throughout the duration of the study (1 Year)

Study Arms (2)

Control

ACTIVE COMPARATOR

etafilcon A contact lens being worn 7 days/6 nights.

Device: etafilcon A

Test

EXPERIMENTAL

galyfilcon A contact lens being worn 7 days/6 nights.

Device: galyfilcon A

Interventions

etafilcon ADEVICE
Control
galyfilcon ADEVICE
Test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject must be at least 18 years of age.
  • The subject must read and sign the statement of informed consent and be provided with a copy of the form.
  • Minimum of 7 days of successful lens wear
  • Contact lens prescription requiring between -1.00 to -6.00 D spherical power
  • Less than 1.00 D of astigmatism in either eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Steven S. Grant, OD

Costa Mesa, California, 92626, United States

Location

Cole, Cole, and Krohn

Fresno, California, 93704, United States

Location

Fukai and Associates

Louisville, Colorado, 80027, United States

Location

Peter C. Donshik, MD

Bloomfield, Connecticut, 06002, United States

Location

Dr. Ted Brink and Associates

Jacksonville, Florida, 32256, United States

Location

Jack J. Yager, OD

Orlando, Florida, 32803, United States

Location

Clayton Eye Center

Morrow, Georgia, 30260, United States

Location

Eyecare Associates

Bloomington, Illinois, 61701, United States

Location

Drs. Hawks, Besler & Rogers

Gardner, Kansas, 66030, United States

Location

Lee Rigel

East Lansing, Michigan, 48823, United States

Location

Univ Missouri at St. Louis, College of Optometry

St Louis, Missouri, 63121, United States

Location

InSight Eyecare

Warrensburg, Missouri, 64093, United States

Location

Drs. Quinn, Quinn and Associates

Athens, Ohio, 45701, United States

Location

Central Ohio Eyecare

Columbus, Ohio, 43202, United States

Location

Kenji Hamada, OD

Grants Pass, Oregon, 97526, United States

Location

West Hills Vision Center

Moon Township, Pennsylvania, 15108, United States

Location

Kenneth A. Young, OD

Brentwood, Tennessee, 37027, United States

Location

Gary W. Jerkins, MD

Nashville, Tennessee, 37205, United States

Location

Premier Vision

Amarillo, Texas, 79119, United States

Location

Charles Wegman, OD

Carrollton, Texas, 75006, United States

Location

Wishnow-Sugar Vision Group

Katy, Texas, 77450, United States

Location

First Eye Care Plano

Plano, Texas, 75023, United States

Location

Dr. William Bogus

Salt Lake City, Utah, 84106, United States

Location

Scott Jens, OD

Middleton, Wisconsin, 53562, United States

Location

Snowy Range Vision Center

Laramie, Wyoming, 82070, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
David C. Turner, Ph.D. GLOBAL PLATFORM SR DIRECTOR, R&D
Organization
Johnson & Johnson Vision Care, Inc.
DTURNER2@its.jnj.com
904-443-3500

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 18, 2005

Study Start

September 1, 2005

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

March 24, 2016

Results First Posted

February 25, 2016

Record last verified: 2016-02

Locations

US(25)