Silicone Hydrogel Contact Lenses on Low Astigmatism in Japan

Myopia Clinical Trial

Official title:

The Clinical Performance of the Silicone Hydrogel Contact Lens on Low to Moderate Astigmatism in Japan

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00639353
• Other study ID #: CR-0804
• Status: Terminated
• Phase: N/A
• First received: March 14, 2008
• Last updated: October 28, 2014
• Start date: February 2008

Study information

• Verified date: October 2014
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 102
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 39 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Myopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• senofilcon A toric soft contact lens
contact lens
• senofilcon A sphere soft contact lens
contact lens

Locations

Country	Name	City	State
Japan	Shioya eye clinic	Fukushimashi	Fukushima
Japan	Kodama eye clinic	Jyoyoshi	Kyoto
Japan	Kajita eye clinic	Minatoku	Tokyo
Japan	Takahashi eye clinic	Odawarashi	Kanagawa
Japan	Inaba eye clinic	Osakashi	Osaka
Japan	Iwasaki eye clinic	Osakashi	Osaka
Japan	Watanabe eye clinic	Osakashi	Osaka
Japan	Dogenzakaitoi eye clinic	Shibuyaku	Tokyo
Japan	Ueda eye clinic	Shimonosekishi	Yamaguchi
Japan	Sakura eye clinic	Shizuokashi	Shizuoka

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.	Johnson & Johnson

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject-reported satisfaction for vision	Scale of 0 to 100, were 0=extremely poor and 100=Excellent	After 2 weeks of lens wear	No
Primary	Subject-reported satisfaction for comfort.	Scale of 0 to 100, were 0=extremely poor and 100=Excellent	After 2 weeks of lens wear	No
Secondary	Subject preference for lens type.		After 2 weeks of lens wear.	No