Study 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).

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241280
• Other study ID #: CR-1480
• Status: Completed
• Phase: N/A
• First received: October 14, 2005
• Last updated: January 28, 2016
• Start date: September 2005
• Est. completion date: October 2006

Study information

• Verified date: January 2016
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 504
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• etafilcon A

• galyfilcon A

Locations

Country	Name	City	State
United States	Premier Vision	Amarillo	Texas
United States	Drs. Quinn, Quinn and Associates	Athens	Ohio
United States	Peter C. Donshik, MD	Bloomfield	Connecticut
United States	Eyecare Associates	Bloomington	Illinois
United States	Kenneth A. Young, OD	Brentwood	Tennessee
United States	Charles Wegman, OD	Carrollton	Texas
United States	Central Ohio Eyecare	Columbus	Ohio
United States	Steven S. Grant, OD	Costa Mesa	California
United States	Lee Rigel	East Lansing	Michigan
United States	Cole, Cole, and Krohn	Fresno	California
United States	Drs. Hawks, Besler & Rogers	Gardner	Kansas
United States	Kenji Hamada, OD	Grants Pass	Oregon
United States	Dr. Ted Brink and Associates	Jacksonville	Florida
United States	Wishnow-Sugar Vision Group	Katy	Texas
United States	Snowy Range Vision Center	Laramie	Wyoming
United States	Fukai and Associates	Louisville	Colorado
United States	Scott Jens, OD	Middleton	Wisconsin
United States	West Hills Vision Center	Moon Township	Pennsylvania
United States	Clayton Eye Center	Morrow	Georgia
United States	Gary W. Jerkins, MD	Nashville	Tennessee
United States	Jack J. Yager, OD	Orlando	Florida
United States	First Eye Care Plano	Plano	Texas
United States	Dr. William Bogus	Salt Lake City	Utah
United States	Univ Missouri at St. Louis, College of Optometry	St. Louis	Missouri
United States	InSight Eyecare	Warrensburg	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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 events)/(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)	Yes