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Evaluation of Selenium coated lenses

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12606000298516
Enrollment
180
Registered
2006-07-12
Start date
2006-08-20
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 will wear the test selenium lens in one eye and the control marketed lens in the other eye

Sponsors

Institute for Eye Research
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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 criteria

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026