N/A
Completed N=501
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).
Source: ClinicalTrials.gov NCT00241280 ↗Enrolled (actual)
501
Serious AEs
0.2%
Results posted
Feb 2016
Primary outcomePrimary: Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 — 0; 0; 0; 0 Percentage of Subjects Eyes
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Rate of Contact Lens Related Serious and Significant Events (SSE) |
2.4; 5.9 | — |
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
-
Data sourced from ClinicalTrials.gov (NCT00241280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.