The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens

CooperVision

Status: Completed

Conditions: Astigmatism

Treatments: Device: stenfilcon A; Device: etafilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02801006

JP-MKTG-201603

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

41 participants in 2 patient groups

stenfilcon A

Experimental group

Description:

Participants will be randomized to wear stenfilcon A lens pair for two weeks during the cross over study.

Treatment:

Device: stenfilcon A

etafilcon A

Active Comparator group

Description:

Participants will be randomized to wear etafilcon A lens pair for two weeks during the cross over study.

Treatment:

Device: etafilcon A