Silicone Hydrogel Contact Lenses on Low Astigmatism in Japan

Johnson & Johnson (J&J)

Status: Terminated

Conditions: Myopia; Refractive Error; Astigmatism

Treatments: Device: senofilcon A sphere soft contact lens; Device: senofilcon A toric soft contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT00639353

CR-0804

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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102 participants in 2 patient groups

spherical contact lens

Active Comparator group

Description:

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

Treatment:

Device: senofilcon A sphere soft contact lens

toric contact lens

Experimental group

Description:

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

Treatment:

Device: senofilcon A toric soft contact lens