Evaluation of the Performance of Non-molded Soft Contact Lenses
Phase 3
Completed
- Conditions
- Ametropia
- Interventions
- Device: Soft contact lens
- Registration Number
- NCT00371787
- Lead Sponsor
- University of Waterloo
- Brief Summary
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties.
- Detailed Description
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties in a group of participants who present with lens related changes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description soft contact lens Soft contact lens -
- Primary Outcome Measures
Name Time Method Visual Acuity 9 month level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
Neovascularisation baseline length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
Neovascularization 9 month length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centre for Contact Lens Research, University of Waterloo,
🇨🇦Waterloo, Ontario, Canada