Phase 3
N=38
Evaluation of the Performance of Non-molded Soft Contact Lenses
Ametropia
Bottom Line
View on ClinicalTrials.gov: NCT00371787 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Dec 2010
Primary outcome: Primary: Visual Acuity — 0.01; -0.07 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Soft contact lens (Device)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- University of Waterloo
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
0.01; -0.08 | — |
| PRIMARY Visual Acuity |
0.01; -0.08 | — |
| PRIMARY Neovascularisation |
0.84; 0.35 | — |
| PRIMARY Neovascularization |
0.63; 0.35 | — |
Summary
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties.
Eligibility Criteria
Inclusion Criteria
- Male or female, good health, age >17yrs, able to wear contact lenses as primary vision correction, able to see well and achieve good fit with study lens, has understood & signed consent form.
Exclusion Criteria
- Has active ocular disease, uses topical eye medication, wears gas permeable/silicone hydrogel /overnight wear contact lenses, is a participant in another clinical study, is deemed unsuitable for soft contact lens wear.
Data sourced from ClinicalTrials.gov (NCT00371787). 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.