Evaluation of Selenium coated lenses

Phase 1

Recruiting

• Conditions: Contact lens wear; Eye - Normal eye development and function

• Registration Number: ACTRN12606000298516
• Lead Sponsor: Institute for Eye Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether selenium coated lenses are safe and effective for daily and extended wear. The trial will last for up to 6 months.[Assessments will occur on a monthly basis]

Secondary Outcome Measures

Name	Time	Method
To determine whether selenium coated lenses retain antibacterial efficacy after wear.[Lenses will be assessed on after each month of wear.]