Bacterial adhesion to unworn and worn silicone hydrogel lenses

Not Applicable

Not yet recruiting

• Conditions: Effect of lens wear on bacterial adhesion; Eye - Normal eye development and function

• Registration Number: ACTRN12609000230257
• Lead Sponsor: Institute for Eye Reseach

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Be able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
Be at least 18 years old;
Be willing to comply with the 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 participant from safely wearing contact lenses;
Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses at baseline;
Be experienced at wearing contact lenses at baseline;
Owns spectacles with current prescription.

Exclusion Criteria

Pre-existing ocular irritation, injury or condition of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses;
Any systemic disease that adversely affects ocular health and auto-immune diseases;
An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
A need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the trial;
Any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant’s ocular health/physiology or contact lens performance either in an adverse manner or risk providing a false positive.
Eye surgery within 12 weeks immediately prior to enrolment for this trial;
Previous corneal refractive surgery;
Contraindications to contact lens wear;
Currently enrolled in another clinical trial;
Participation in a clinical trial within the previous 2 weeks for dispensing studies.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish baseline data for bacterial adhesion to unworn silicone hydrogel lenses. Outcome will be assessed using microbial adhesion assay and recovery of viable bacteria attached on the lens surface.[Six (6) months from baseline.];To identify whether lens wear changes the level of bacterial adhesion to individual lens types.Outcome will be assessed using microbial adhesion assay and recovery of viable bacteria attached on the lens surface.[Six (6) months from baseline]

Secondary Outcome Measures

Name	Time	Method
Identify whether lens wear alters the relative ranking of bacterial adhesion to lenses.Outcome will be assessed using microbial adhesion assay and recovery of viable bacteria attached on the lens surface and comparison of the results between worn and unworn lenses.[Six (6) months from baseline.]