The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coopervision, Inc.
- Enrollment
- 41
- Locations
- 2
- Primary Endpoint
- Comfort
Study Overview
Brief Summary
The aim of this study is to evaluate the clinical performance of stenfilcon A toric lenses compared with etafilcon A toric lenses for astigmatism. If it is valuable, the clinical performance of stenfilcon A toric lens is also evaluated compared with habitual lenses.
Detailed Description
This is a multi-sites, 50 subjects, randomized, open labeled, bilateral wear, dispensing study. Participants will be randomized to wear first lens pair for two weeks, and then crossover to second lens pair for two weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 42 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •A person is eligible for inclusion in the study if he/she:
- •Is between 18 years of age and 42 years of age.
- •Soft contact lens wearers who are not required to have Presbyopic correction.
- •Soft contact lens wearers without trouble.
- •Soft contact lens wearers who have the correctable astigmatism by lenses used in this study in the both eyes.
- •Has a prescribed SCL (Soft Contact Lens) power within the range of powers of the SCL for astigmatism which is used in this study.
- •Can achieve a corrected visual acuity of 1.0 or better.
- •Can read and understand the study information document, and sign the participation consent form.
- •Can visit the clinic at designated examination visits.
- •Has received periodical examinations at an eye clinic within the past two years.
Exclusion Criteria
- •A person will be excluded from the study if he/she:
- •Has a systemic disease that may affect the ocular health.
- •Is pregnant or lactating.
- •Has received a systemic or local medication that may affect this study.
- •Has an infectious eye disease.
- •Has eye and systemic active allergic diseases that interferes with SCL wear.
- •Has an eye disease which is clinically judged to be severe such as corneal vascularization, limbal hyperemia, and corneal epithelium disorder
- •Has a history of hard contact lens wear within 30 days.
- •Is currently participating in another clinical research study.
- •Has undergone refractive surgery.
Arms & Interventions
stenfilcon A
Participants will be randomized to wear stenfilcon A lens pair for two weeks during the cross over study.
Intervention: stenfilcon A (Device)
etafilcon A
Participants will be randomized to wear etafilcon A lens pair for two weeks during the cross over study.
Intervention: etafilcon A (Device)
Outcomes
Primary Outcomes
Comfort
Time Frame: 2 weeks
Wearing comfort (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0= extremely uncomfortable cannot wear at all, 10=very comfortable and feel no lens at all
Dryness
Time Frame: 2 weeks
Dryness (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=extremely dried and cannot wear lens, 10=feel no dryness at all
Stability of Vision
Time Frame: 2 weeks
Stability of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=unstable vision and cannot see at all, 10=always stable vision
Clarity of Vision
Time Frame: 2 weeks
Clarity of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=blur vision and cannot see at all, 10=very clear with no blur vision at all
Lens Handling
Time Frame: 2 weeks
Lens handling for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=cannot handle at all, 10=no problem at all
Overall Satisfaction
Time Frame: 2 weeks
Overall satisfaction for stenfilcon A and etafilcon A toric lens pair is assessed. scale 0-10, 0=extremely un-satisfy, 10=very satisfy
Secondary Outcomes
No secondary outcomes reported