Effect of lens wear on bacterial adhesion to lens surfaces

Not Applicable

Completed

• Conditions: Protein and lipid deposition on the surface of silicone hydrogel lenses during daily wear and extended wear of contact lenses; Eye - Normal eye development and function

• Registration Number: ACTRN12608000557336
• Lead Sponsor: Institute for Eye Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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;
Have experienced an ocular adverse event that is not considered to be severe by the Investigator (Investigator discretion) or that is temporary in nature;
Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
Be experienced or may be inexperienced at wearing contact lenses

Exclusion Criteria

Pre-existing ocular irritation, injury or condition that would preclude contact lens fitting and safe wearing of contact lenses;
any systemic disease that adversely affects ocular health; active corneal infection or any active ocular disease that would affect wearing of contact lenses;
previously experienced a severe contact lens related adverse event (Investigator discretion), that is likely to affect their contact lens wear experience or present a significant safety risk during the trial;
any prescribed 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 or beneficial manner;
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;pregnant or lactating women who are not able to complete the study (Investigator discretion).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To identify the proteins and lipids that deposit on a lens surface and to determine which proteins and lipids mediate bacterial adhesion to the lens surface. Extracted proteins to be separated by nano-Liquid Chromatography (LC) and Mass Spectrometry (MS). Concentration of each protein determined by Enzyme-Linked ImmunoSorbent Assay (ELISA). Extracted lipids to be separated by Thin Layer Chromatography (TLC) and amounts of lipids measured using standard curves on TLC plates.[At 1 month, 2 months and 3 months from the baseline visit]

Secondary Outcome Measures

Name	Time	Method
/A[N/A]