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The Effect of Silicone Hydrogel Contact Lenses on Conjunctival Flora

U

University of Melbourne

Status

Completed

Conditions

Myopia

Treatments

Device: Silicone hydrogel contact lens

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00531375
H07 003

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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