Silicone Hydrogel Contact Lenses on Low Astigmatism in Japan

NCT00639353 | Terminated

• 1 other identifier: CR-0804
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 10

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

Outcome Measures

Primary Outcomes (2)

• Subject-reported satisfaction for vision

  Scale of 0 to 100, were 0=extremely poor and 100=Excellent

  After 2 weeks of lens wear

• Subject-reported satisfaction for comfort.

  Scale of 0 to 100, were 0=extremely poor and 100=Excellent

  After 2 weeks of lens wear

Secondary Outcomes (1)

• Subject preference for lens type.

  After 2 weeks of lens wear.

Study Arms (2)

spherical contact lens

ACTIVE COMPARATOR

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

Device: senofilcon A sphere soft contact lens

toric contact lens

EXPERIMENTAL

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

Device: senofilcon A toric soft contact lens

Interventions

senofilcon A toric soft contact lens DEVICE

contact lens

Also known as: ACUVUE OASYS for Astigmatism

toric contact lens

senofilcon A sphere soft contact lens DEVICE

contact lens

Also known as: ACUVUE OASYS

spherical contact lens

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 permeable).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead
• Johnson & Johnson: collaborator

Study Sites (10)

Shioya eye clinic

Fukushima, Fukushima, Japan

Location

Takahashi eye clinic

Odawarashi, Kanagawa, Japan

Location

Kodama eye clinic

Jyoyoshi, Kyoto, Japan

Location

Inaba eye clinic

Osakashi, Osaka, Japan

Location

Iwasaki eye clinic

Osakashi, Osaka, Japan

Location

Watanabe eye clinic

Osakashi, Osaka, Japan

Location

Sakura eye clinic

Shizuoka, Shizuoka, Japan

Location

Kajita eye clinic

Minatoku, Tokyo, Japan

Location

Dogenzakaitoi eye clinic

Shibuyaku, Tokyo, Japan

Location

Ueda eye clinic

Shimonosekishi, Yamaguchi, Japan

Location

MeSH Terms

Conditions

Refractive Errors; Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2008
• First Posted: March 20, 2008
• Study Start: February 1, 2008
• Primary Completion: June 1, 2008
• Last Updated: October 29, 2014

Record last verified: 2014-10

Locations

JP (10)