Clinical trial NCT02801006: The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens
Official title: The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2016-06-15
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comfort
timeFrame: 2 weeks
measure: Dryness
timeFrame: 2 weeks
measure: Clarity of Vision
timeFrame: 2 weeks
measure: Stability of Vision
timeFrame: 2 weeks
measure: Lens Handling
timeFrame: 2 weeks
measure: Overall Satisfaction
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Terada
country: Japan
facility: Kodama Eye Clinic
state: Kyoto
city: Shibuya
country: Japan
facility: Dougenzaka Ioti Eye Clinic
state: Tokyo-to
Study officials:
affiliation: Director, Kodama Eye Clinic
name: Yuji Kodama, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: