N/A
Completed N=76
Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens
Source: ClinicalTrials.gov NCT00754338 ↗Enrolled (actual)
76
Serious AEs
—
Results posted
Sep 2010
Primary outcomePrimary: Comfort — 86; 86; 87; 86 Units on a scale
Summary
The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comfort |
86; 86; 87; 86 | — |
| PRIMARY Lens Wettability |
0.71; 0.72; 0.92; 1.21 | — |
| PRIMARY Lens Deposits |
0.51; 0.54; 0.62; 0.93 | — |
| SECONDARY Dryness |
85; 86; 85; 85 | — |
| SECONDARY Subjective Vision |
89; 89; 90; 90 | — |
| SECONDARY Corneal Staining |
47; 55; 52; 322 | — |
Eligibility Criteria
Inclusion Criteria
- Is at least 17 years of age and has full legal capacity to volunteer.
- Has read, understood and signed an information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
- Has clear corneas and no active ocular disease.
- Has had an ocular examination in the last two years.
- Is a current soft lens wearer, replacing their lenses every two weeks to one month.
- Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fit with the study lens.
- Has astigmatism less than or equal to -1.00 DC.
Exclusion Criteria
- Has any signs or symptoms of dry eye.
- Has any clinically significant blepharitis.
- Has undergone corneal refractive surgery.
- Is aphakic.
- Has any active ocular disease.
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that may affect ocular health.
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
- Is pregnant or lactating.
- Is participating in any other type of clinical or research study.
- Currently wears daily disposable lenses.
- Currently wears lenses on an extended wear basis.
Data sourced from ClinicalTrials.gov (NCT00754338). 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.