Clinical trial NCT00639353: Silicone Hydrogel Contact Lenses on Low Astigmatism in Japan
Official title: The Clinical Performance of the Silicone Hydrogel Contact Lens on Low to Moderate Astigmatism in Japan
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Refractive Error
Myopia
Astigmatism
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson
First posted: 2008-03-20
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Subject-reported satisfaction for vision
timeFrame: After 2 weeks of lens wear
measure: Subject-reported satisfaction for comfort.
timeFrame: After 2 weeks of lens wear
Secondary outcomes:
measure: Subject preference for lens type.
timeFrame: After 2 weeks of lens wear.
Other outcomes:
Locations:
city: Fukushimashi
country: Japan
facility: Shioya eye clinic
state: Fukushima
city: Odawarashi
country: Japan
facility: Takahashi eye clinic
state: Kanagawa
city: Jyoyoshi
country: Japan
facility: Kodama eye clinic
state: Kyoto
city: Osakashi
country: Japan
facility: Inaba eye clinic
state: Osaka
city: Osakashi
country: Japan
facility: Iwasaki eye clinic
state: Osaka
city: Osakashi
country: Japan
facility: Watanabe eye clinic
state: Osaka
city: Shizuokashi
country: Japan
facility: Sakura eye clinic
state: Shizuoka
city: Minatoku
country: Japan
facility: Kajita eye clinic
state: Tokyo
city: Shibuyaku
country: Japan
facility: Dogenzakaitoi eye clinic
state: Tokyo
city: Shimonosekishi
country: Japan
facility: Ueda eye clinic
state: Yamaguchi
Study officials:
References: