Clinical Performance of Extended Wear Silicone Hydrogel Lenses

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00441233
• Other study ID #: H07 001
• Status: Completed
• Phase: N/A
• First received: February 27, 2007
• Last updated: December 27, 2007
• Start date: March 2007
• Est. completion date: December 2007

Study information

• Verified date: December 2007
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to investigate the clinical performance of a new silicone hydrogel contact lens over a period of 6 months of extended wear.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2007
• Est. primary completion date: November 2007
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Is correctable to at least 6/9 distance visual acuity in each eye with spherical contact lenses.

• Is a current daily wear soft contact lens wearer.

• Has no clinically significant anterior eye findings.

• Has no other active ocular disease.

Exclusion Criteria:

• Has any systemic disease that might interfere with contact lens wear

• Is using any systemic or topical medications that will affect ocular health.

• Has any pre-existing ocular irritation that would preclude contact lens fitting.

• Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.

• Has undergone corneal refractive surgery.

• Is pregnant, lactating or planning a pregnancy.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Silicone hydrogel contact lens

Locations

Country	Name	City	State
Australia	Clinical Vision Research Australia	Melbourne	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
University of Melbourne	Clinical Vision Research Australia, Menicon Co., Ltd.

Country where clinical trial is conducted

Australia,