N/A
Completed N=33
BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study
Source: ClinicalTrials.gov NCT02537730 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcomePrimary: Ocular Health - Corneal Staining — 45; 53; 21; 13 Eyes
Summary
Two week, Open Label, randomized, bilateral, crossover, 1 week of daily wear in each combination (lens / disinfecting cleaning system).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Health - Corneal Staining |
45; 53; 21; 13; 0; 0 | — |
| SECONDARY Comfort |
9.24; 9.30; 9.52; 9.44; 8.99; 9.10 | — |
| SECONDARY Dryness |
9.67; 9.77; 9.27; 9.38; 8.65; 8.91 | — |
| SECONDARY Stinging and Burning Sensation |
9.42; 9.50; 9.97; 9.91 | — |
Eligibility Criteria
Inclusion Criteria
- Is over 18 years of age (inclusive)
- Has had a self-reported visual exam in the last two years
- Has a CL (contact lens) spherical prescription between -0.25D (Diopters) and -12.00D (inclusive)
- Has less than 1.00 D spectacle cylinder in each eye
- Is correctable to a visual acuity of 20/20 or better in both eyes
- Has clear corneas and no active ocular disease
- Has read, understood and signed the informed consent letter
- Is willing to comply with the wear schedule (at least 40hrs per week)
- Is willing to comply with the visit schedule
Exclusion Criteria
- Has never worn contact lenses before
- Currently wears rigid gas permeable contact lens
- Has a history of not achieving comfortable CL (contact lens) wear (5 days per week; > 8 hours per day)
- Has a CL prescription outside the range of -0.25D to -12.00D
- Has a spectacle cylinder greater than -0.75D of cylinder in either eye
- Has best corrected spectacle distant vision worse than 20/20 in ether eye
- Has any systemic disease affecting ocular health
- Is using any systemic or topical medications that will affect ocular health
- Has any ocular pathology or sever insufficiency of lacrimal secretion
- Has persistent, clinically significant corneal or conjunctival staining
- Has active neovascularization or any central corneal scars
- Is aphakic
- Is pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT02537730). 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.