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).

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: galyfilcon A; Device: etafilcon A

• Registration Number: NCT00241280
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-10-14
• Study First Submitted QC: 2005-10-14
• Study First Posted: 2005-10-18
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Results First Submitted: 2015-12-04
• Results First Submitted QC: 2016-01-28
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-24
• Results First Posted: 2016-02-25
• Last Update Posted: 2016-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 504

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	galyfilcon A	galyfilcon A contact lens being worn 7 days/6 nights.
Control	etafilcon A	etafilcon A contact lens being worn 7 days/6 nights.

Primary Outcome Measures

Name	Time	Method
Rate of Contact Lens Related Serious and Significant Events (SSE)	Throughout the duration of the study (1 Year)	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.
Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40	Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks	Percentage of subject eyes reported with visual acuity worse than 20/40 at each study visit.

Trial Locations

Locations (25)

Steven S. Grant, OD; 🇺🇸 Costa Mesa, California, United States

Cole, Cole, and Krohn; 🇺🇸 Fresno, California, United States

Fukai and Associates; 🇺🇸 Louisville, Colorado, United States

Peter C. Donshik, MD; 🇺🇸 Bloomfield, Connecticut, United States

Dr. Ted Brink and Associates; 🇺🇸 Jacksonville, Florida, United States

Jack J. Yager, OD; 🇺🇸 Orlando, Florida, United States

Clayton Eye Center; 🇺🇸 Morrow, Georgia, United States

Eyecare Associates; 🇺🇸 Bloomington, Illinois, United States

Drs. Hawks, Besler & Rogers; 🇺🇸 Gardner, Kansas, United States

Lee Rigel; 🇺🇸 East Lansing, Michigan, United States

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