Silicone Hydrogel Contact Lenses on Low Astigmatism in Japan

Not Applicable

Terminated

• Conditions: Refractive Error; Myopia; Astigmatism
• Interventions: Device: senofilcon A sphere soft contact lens; Device: senofilcon A toric soft contact lens

• Registration Number: NCT00639353
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary

This study seeks to evaluate the clinical performance of a recently released contact lens designed to correct astigmatism to an established contact lens that has historically been used in these patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-14
• Study First Submitted QC: 2008-03-14
• Study First Posted: 2008-03-20
• Primary Completion: 2008-06
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-28
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

1. The subject is 18 to 39 years of age. (Parental consent is required for a minor child i.e. under the age of 20.)
2. The subject has signed an informed consent with his/her own judgement for participation in the study.
3. The subject currently is a habitual wearer of spherical or toric daily-wear soft contact lenses, excluding daily disposables, in daily wear bases.

Exclusion Criteria

1. The subject has any ocular or systemic allergies that interfere with contact lens wear.
2. The subject has dry eye and lacrimal apparatus disease that could interfere with contact lens wear.
3. The subject has any systemic disease or autoimmune disease that interferes with contact lens wear.
4. The subject has corneal edema, neovascularization, corneal staining or other ocular abnormalities (Grade 3 or above) that clinically apparently interfere with contact lens wear.
5. The subject has any anterior segment eye disease (palpebral abnormalities, corneal hypesthesia, corneal epithelial defect, bulbar conjunctival hyperemia, etc.) that clinically apparently interferes with contact lens wear.
6. The subject has a history of solution reactions to the chemical cleaner/disinfectant to be used in this study, as far as known to the subject.
7. The subject has ocular infection.
8. The subject has ocular inflammation (including acute/subacute anterior segment inflammations and uveitis).
9. The subject has corneal distortion resulting from previous experience of hard contact lens wear.
10. The subject has infectious disease (pneumonia, tuberculosis, etc.) or immunosuppressive disease (HIV positive etc.), as far as known to the subject.
11. The subject has diabetes, as far as known to the subject.
12. The subject is pregnant or in the lactation period, as far as known to the subject.
13. The subject uses any eye remedies (excluding artificial tear substitutes or hyaluronic acid drops for reducing dryness while wearing contact lenses).
14. The subject had any ocular trauma or surgery within 8 weeks prior to participation in the study.
15. The subject is a wearer of hard contact lenses (including rigid gas permeable).
16. The subject is exposed to a dry environment on a constant basis.
17. The subject is exposed to a living environment where dust, chemicals, etc. can easily enter the eye.
18. The subject is unable to follow the principal investigator's instructions.
19. The subject is unable to follow lens hygiene procedures necessary for contact lens wear.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
spherical contact lens	senofilcon A sphere soft contact lens	Subjects will wear and evaluate a spherical soft contact lens daily for 2 weeks
toric contact lens	senofilcon A toric soft contact lens	Subjects will wear and evaluate a toric soft contact lens daily for 2 weeks

Primary Outcome Measures

Name	Time	Method
Subject-reported satisfaction for vision	After 2 weeks of lens wear	Scale of 0 to 100, were 0=extremely poor and 100=Excellent
Subject-reported satisfaction for comfort.	After 2 weeks of lens wear	Scale of 0 to 100, were 0=extremely poor and 100=Excellent

Secondary Outcome Measures

Name	Time	Method
Subject preference for lens type.	After 2 weeks of lens wear.

Trial Locations

Locations (10)

Shioya eye clinic; 🇯🇵 Fukushimashi, Fukushima, Japan

Takahashi eye clinic; 🇯🇵 Odawarashi, Kanagawa, Japan

Inaba eye clinic; 🇯🇵 Osakashi, Osaka, Japan

Kodama eye clinic; 🇯🇵 Jyoyoshi, Kyoto, Japan

Iwasaki eye clinic; 🇯🇵 Osakashi, Osaka, Japan

Sakura eye clinic; 🇯🇵 Shizuokashi, Shizuoka, Japan

Kajita eye clinic; 🇯🇵 Minatoku, Tokyo, Japan

Dogenzakaitoi eye clinic; 🇯🇵 Shibuyaku, Tokyo, Japan

Watanabe eye clinic; 🇯🇵 Osakashi, Osaka, Japan

Ueda eye clinic; 🇯🇵 Shimonosekishi, Yamaguchi, Japan