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).

Johnson & Johnson Vision Care, Inc.504 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

504

Conditions

Myopia

Interventions

etafilcon ADEVICE

galyfilcon ADEVICE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: \-

Locations (25)

Steven S. Grant, OD

Costa Mesa, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Throughout the duration of the study (1 Year)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.