Silicone Hydrogel Contact Lenses on Low Astigmatism in Japan

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

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.

Study Overview

• Status: Terminated
• Conditions: Refractive Error; Astigmatism; Myopia
• Intervention / Treatment: Device: senofilcon A sphere soft contact lens; Device: senofilcon A toric soft contact lens

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: spherical contact lens; Subjects will wear and evaluate a spherical soft contact lens daily for 2 weeks	Device: senofilcon A sphere soft contact lens; contact lens; Other Names: ACUVUE OASYS
Experimental: toric contact lens; Subjects will wear and evaluate a toric soft contact lens daily for 2 weeks	Device: senofilcon A toric soft contact lens; contact lens; Other Names: ACUVUE OASYS for Astigmatism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Subject preference for lens type.	After 2 weeks of lens wear.

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Collaborators: Johnson & Johnson

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: March 14, 2008
• First Submitted That Met QC Criteria: March 14, 2008
• First Posted (Estimate): March 20, 2008

Study Record Updates

• Last Update Posted (Estimate): October 29, 2014
• Last Update Submitted That Met QC Criteria: October 28, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: CR-0804