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 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).

Completed

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steven S. Grant, OD, Costa Mesa, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etafilcon A

Device

galyfilcon A

Device

Primary outcomes

Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40

Time frame: 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.
Rate of Contact Lens Related Serious and Significant Events (SSE)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Oct 18, 2005
Registry last updated: Mar 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed