The Effect of Silicone Hydrogel Contact Lenses on Conjunctival Flora

NCT00531375 | Completed

• 1 other identifier: H07 003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to investigate the effect of silicone hydrogel contact lenses on conjunctival flora over a period of 6 months of daily wear. A secondary aim is to compare the levels of microbial contamination of silicone hydrogel lenses after daily wear.

Conditions

Myopia

Interventions

Silicone hydrogel contact lens DEVICE

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is correctable to at least 6/9 distance visual acuity in each eye with spherical contact lenses.
• Is a current full time soft contact lens wearer.
• Has no clinically significant anterior eye findings.
• Has no other active ocular disease

You may not qualify if:

• 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.
• Is participating in a concurrent clinical trial.
• Has a latex sensitivity.

Sponsors & Collaborators

• University of Melbourne: lead
• Clinical Vision Research Australia: collaborator
• Johnson & Johnson Vision Care, Inc.: collaborator

Study Sites (1)

Clinical Vision Research Australia

Melbourne, Victoria, 3053, Australia

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Carol Lakkis, BScOptom, PhD, PGCertOcTher

  Clinical Vision Research Australia, Victorian College of Optometry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 17, 2007
• First Posted: September 18, 2007
• Study Start: September 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: September 1, 2008
• Last Updated: November 19, 2008

Record last verified: 2008-11

Locations

AU (1)