Silicone Hydrogel Contact Lenses on Low Astigmatism in Japan

NCT ID: NCT00639353

Last Updated: 2014-10-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29

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.

Conditions

Refractive Error; Myopia; Astigmatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

spherical contact lens

Subjects will wear and evaluate a spherical soft contact lens daily for 2 weeks

Group Type: ACTIVE_COMPARATOR

senofilcon A sphere soft contact lens

Intervention Type: DEVICE

contact lens

toric contact lens

Subjects will wear and evaluate a toric soft contact lens daily for 2 weeks

Group Type: EXPERIMENTAL

senofilcon A toric soft contact lens

Intervention Type: DEVICE

contact lens

Interventions

senofilcon A toric soft contact lens

contact lens

Intervention Type: DEVICE

senofilcon A sphere soft contact lens

contact lens

Intervention Type: DEVICE

Other Intervention Names

ACUVUE OASYS for Astigmatism; ACUVUE OASYS

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson

INDUSTRY

Sponsor Role: collaborator

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shioya eye clinic

Fukushima, Fukushima, Japan

Takahashi eye clinic

Odawarashi, Kanagawa, Japan

Kodama eye clinic

Jyoyoshi, Kyoto, Japan

Inaba eye clinic

Osakashi, Osaka, Japan

Iwasaki eye clinic

Osakashi, Osaka, Japan

Watanabe eye clinic

Osakashi, Osaka, Japan

Sakura eye clinic

Shizuoka, Shizuoka, Japan

Kajita eye clinic

Minatoku, Tokyo, Japan

Dogenzakaitoi eye clinic

Shibuyaku, Tokyo, Japan

Ueda eye clinic

Shimonosekishi, Yamaguchi, Japan

Countries

Japan

Other Identifiers

CR-0804

Identifier Type: -

Identifier Source: org_study_id