Clinical trial NCT00241280: 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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).


Eligibility criteria: 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:

-

Primary outcomes:
measure: Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40
timeFrame: Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks
measure: Rate of Contact Lens Related Serious and Significant Events (SSE)
timeFrame: Throughout the duration of the study (1 Year)
Secondary outcomes:
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Steven S. Grant, OD
state: California
city: Fresno
country: United States
facility: Cole, Cole, and Krohn
state: California
city: Louisville
country: United States
facility: Fukai and Associates
state: Colorado
city: Bloomfield
country: United States
facility: Peter C. Donshik, MD
state: Connecticut
city: Jacksonville
country: United States
facility: Dr. Ted Brink and Associates
state: Florida
city: Orlando
country: United States
facility: Jack J. Yager, OD
state: Florida
city: Morrow
country: United States
facility: Clayton Eye Center
state: Georgia
city: Bloomington
country: United States
facility: Eyecare Associates
state: Illinois
city: Gardner
country: United States
facility: Drs. Hawks, Besler & Rogers
state: Kansas
city: East Lansing
country: United States
facility: Lee Rigel
state: Michigan
city: St. Louis
country: United States
facility: Univ Missouri at St. Louis, College of Optometry
state: Missouri
city: Warrensburg
country: United States
facility: InSight Eyecare
state: Missouri
city: Athens
country: United States
facility: Drs. Quinn, Quinn and Associates
state: Ohio
city: Columbus
country: United States
facility: Central Ohio Eyecare
state: Ohio
city: Grants Pass
country: United States
facility: Kenji Hamada, OD
state: Oregon
city: Moon Township
country: United States
facility: West Hills Vision Center
state: Pennsylvania
city: Brentwood
country: United States
facility: Kenneth A. Young, OD
state: Tennessee
city: Nashville
country: United States
facility: Gary W. Jerkins, MD
state: Tennessee
city: Amarillo
country: United States
facility: Premier Vision
state: Texas
city: Carrollton
country: United States
facility: Charles Wegman, OD
state: Texas
city: Katy
country: United States
facility: Wishnow-Sugar Vision Group
state: Texas
city: Plano
country: United States
facility: First Eye Care Plano
state: Texas
city: Salt Lake City
country: United States
facility: Dr. William Bogus
state: Utah
city: Middleton
country: United States
facility: Scott Jens, OD
state: Wisconsin
city: Laramie
country: United States
facility: Snowy Range Vision Center
state: Wyoming
Study officials:
References: