RecruitingPhase 2ACTRN12606000298516

Evaluation of Selenium coated lenses

Evaluation of the safety and efficacy of selenium-coated contact lenses


Sponsor

Institute for Eye Research

Enrollment

180 participants

Start Date

Aug 20, 2006

Study Type

Interventional

Conditions

Summary

To determine whether contact lenses containing selenium can be worn safely and prevent bacterial colonisation of their surface. Both the dispensing optometrists and contact lens wearers will be masked.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Be able to read, comprehend and give informed consent as demonstrated by signing a record of informed consent.• be willing to comply with the lens wearing and clinical trial visit schedule as directed by the Investigator.• have ocular health findings considered to be “normal” and which would not prevent the subject from safely wearing contact lenses.• have vision correctable to at least 20/40 or better in each eye with spherical contact lenses.

Exclusion Criteria1

  • Contraindications to hydrogel contact lens wear.• any systemic or ocular disease or active condition or use of medications that may affect the eye or be exacerbated by wearing contact lenses.• pre-existing ocular irritation that would preclude contact lens fitting.• undergone eye surgery in the 12 weeks immediately prior to enrolment for the trial.• undergone corneal refractive surgery.

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Interventions

Comparison of performance of selenium-coated contact lenses to that of high oxygen permeable lenses when worn on a monthly replacement daily or continuous wear schedule for up to 6 months. Subjects wi

Comparison of performance of selenium-coated contact lenses to that of high oxygen permeable lenses when worn on a monthly replacement daily or continuous wear schedule for up to 6 months. Subjects will wear the test selenium lens in one eye and the control marketed lens in the other eye


Locations(1)

Australia

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ACTRN12606000298516