Evaluation of the Performance of Non-molded Soft Contact Lenses
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University of Waterloo
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Visual Acuity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 17 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
soft contact lens
Intervention: Soft contact lens (Device)
non-lens wear
control group
Outcomes
Primary Outcomes
Visual Acuity
Time Frame: 9 month
level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
Neovascularisation
Time Frame: baseline
length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
Neovascularization
Time Frame: 9 month
length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
Visual Acuity
Time Frame: baseline
level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
Secondary Outcomes
No secondary outcomes reported