Phase 3
N=270
Evaluation of an Investigational Multi-Purpose Solution (MPS)
Study Focus is Healthy Contact Lens Wearers
Bottom Line
View on ClinicalTrials.gov: NCT00961051 ↗Enrolled (actual)
270
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Mean Lens Cleanliness as Measured by Light Reflectance — 65.5; 66.8 light reflectance score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Investigational MPS (Device); Opti-Free (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Optics
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Lens Cleanliness as Measured by Light Reflectance |
65.5; 66.8 | — |
| SECONDARY Number of Subjects With no Corneal Staining |
129; 64 | — |
Summary
The purpose of this study is to evaluate the safety and effectiveness of an investigational multi-purpose contact lens solution.
Eligibility Criteria
Inclusion Criteria
- Have successfully worn hydrogel contact lenses of the same material to be worn during the study
- Have normal eyes (with the exception of unaided visual acuity)
- Have successfully used a multi-purpose contact lens care solution
- Have acceptable visual acuity and lens wearing comfort at time of enrollment
Exclusion Criteria
- Concurrently enrolled another clinical trial
- Have a known sensitivity to any study product ingredient(s)
- Have a condition that may put them at significant risk
Data sourced from ClinicalTrials.gov (NCT00961051). 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.