N/A
N=300
Investigational Multi-purpose Contact Lens Care Solution.
Contact Lens Wear
Bottom Line
View on ClinicalTrials.gov: NCT01055613 ↗Enrolled (actual)
300
Serious AEs
0.3%
Results posted
Aug 2016
Primary outcome: Primary: Slit Lamp Findings — 11; 16; 0; 0 Subjects Eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vistakon Investigational Multi-Purpose Solution I (Device); ReNu MultiPlus Multi-Purpose Solution (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Slit Lamp Findings |
11; 16; 0; 0; 14; 12 | — |
| PRIMARY Distance Visual Acuity (LogMAR) |
-0.030; -0.031 | — |
Summary
This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.
Eligibility Criteria
Inclusion Criteria
- must be an adapted contact lens wearer
- best corrected distance visual acuity must be 20/25 or better in each eye
- must be wearing their habitual lenses on a daily wear basis
- must be willing to refrain from swimming during the study
Exclusion Criteria
- any systemic diseases that may interfere with contact lens wear
- any clinically significant ocular disease
- any ocular infection
- use of certain medications
- any grade 2 or greater slit lamp findings
- any know sensitivity to marketed contact lens care solutions
- currently pregnant or lactating
- monovision corrected
Data sourced from ClinicalTrials.gov (NCT01055613). 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.