Silicone Hydrogel Contact Lenses on Low Astigmatism in Japan - Full Text View

Sponsors and Collaborators:	Vistakon Johnson & Johnson
Information provided by:	Vistakon
ClinicalTrials.gov Identifier:	NCT00639353

Purpose

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.

Condition	Intervention
Refractive Error Myopia Astigmatism	Device: senofilcon A toric Device: senofilcon A sphere

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Crossover Assignment
Official Title:	The Clinical Performance of the Silicone Hydrogel Contact Lens on Low to Moderate Astigmatism in Japan

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear Refractive Errors

Drug Information available for: Senofilcon A Silicone

U.S. FDA Resources

Further study details as provided by Vistakon:

Primary Outcome Measures:

Patient-reported satisfaction for vision and comfort. [ Time Frame: After 2 weeks of lens wear ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient preference for lens type. [ Time Frame: After 2 weeks of lens wear. ] [ Designated as safety issue: No ]

Enrollment:	102
Study Start Date:	February 2008
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator spherical contact lens	Device: senofilcon A sphere contact lens
2: Experimental toric contact lens	Device: senofilcon A toric contact lens

Eligibility

Ages Eligible for Study:	18 Years to 39 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The subject is 18 to 39 years of age. (Parental consent is required for a minor child i.e. under the age of 20.)
The subject has signed an informed consent with his/her own judgement for participation in the study.
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:

The subject has any ocular or systemic allergies that interfere with contact lens wear.
The subject has dry eye and lacrimal apparatus disease that could interfere with contact lens wear.
The subject has any systemic disease or autoimmune disease that interferes with contact lens wear.
The subject has corneal edema, neovascularization, corneal staining or other ocular abnormalities (Grade 3 or above) that clinically apparently interfere with contact lens wear.
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.
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.
The subject has ocular infection.
The subject has ocular inflammation (including acute/subacute anterior segment inflammations and uveitis).
The subject has corneal distortion resulting from previous experience of hard contact lens wear.
The subject has infectious disease (pneumonia, tuberculosis, etc.) or immunosuppressive disease (HIV positive etc.), as far as known to the subject.
The subject has diabetes, as far as known to the subject.
The subject is pregnant or in the lactation period, as far as known to the subject.
The subject uses any eye remedies (excluding artificial tear substitutes or hyaluronic acid drops for reducing dryness while wearing contact lenses).
The subject had any ocular trauma or surgery within 8 weeks prior to participation in the study.
The subject is a wearer of hard contact lenses (including rigid gas permeables).
The subject is exposed to a dry environment on a constant basis.
The subject is exposed to a living environment where dust, chemicals, etc. can easily enter the eye.
The subject is unable to follow the principal investigator's instructions.
The subject is unable to follow lens hygiene procedures necessary for contact lens wear.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639353

Locations

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

Sponsors and Collaborators

Vistakon

Johnson & Johnson

More Information

No publications provided

Responsible Party:	Vistakon ( Kurt Moody OD, FAOO, Associate Director, Clinical Research )
Study ID Numbers:	CR-0804
Study First Received:	March 14, 2008
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00639353 History of Changes
Health Authority:	Japan: Institutional Review Board

Study placed in the following topic categories:

Eye Diseases
Myopia
Astigmatism
Refractive Errors

Additional relevant MeSH terms:

Eye Diseases
Refractive Errors
Astigmatism

ClinicalTrials.gov processed this record on September 10, 2009