Silicone Hydrogel Contact Lenses on Low Astigmatism in Japan

This study has been terminated.
(English to Japanese translation issues caused enrollment of incorrect and unqualified subjects; error applied to all subjects enrolled prior to termination.)
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00639353
First received: March 14, 2008
Last updated: May 13, 2013
Last verified: May 2013
  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 soft contact lens
Device: senofilcon A sphere soft contact lens

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

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Subject-reported satisfaction for vision [ Time Frame: After 2 weeks of lens wear ] [ Designated as safety issue: No ]
    Scale of 0 to 100, were 0=extremely poor and 100=Excellent

  • Subject-reported satisfaction for comfort. [ Time Frame: After 2 weeks of lens wear ] [ Designated as safety issue: No ]
    Scale of 0 to 100, were 0=extremely poor and 100=Excellent


Secondary Outcome Measures:
  • Subject preference for lens type. [ Time Frame: After 2 weeks of lens wear. ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: February 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: ACUVUE OASYS for Astigmatism

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
Shioya eye clinic
Fukushimashi, Fukushima, Japan
Takahashi eye clinic
Odawarashi, Kanagawa, Japan
Kodama eye clinic
Jyoyoshi, Kyoto, Japan
Inaba eye clinic
Osakashi, Osaka, Japan
Iwasaki eye clinic
Osakashi, Osaka, Japan
Watanabe eye clinic
Osakashi, Osaka, Japan
Sakura eye clinic
Shizuokashi, Shizuoka, Japan
Kajita eye clinic
Minatoku, Tokyo, Japan
Dogenzakaitoi eye clinic
Shibuyaku, Tokyo, Japan
Ueda eye clinic
Shimonosekishi, Yamaguchi, Japan
Sponsors and Collaborators
Vistakon
Johnson & Johnson
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00639353     History of Changes
Other Study ID Numbers: CR-0804
Study First Received: March 14, 2008
Last Updated: May 13, 2013
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Astigmatism
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 19, 2014