Bacterial contamination of antibacterial contact lens cases during daily wear of marketed contact lenses

Not Applicable

Completed

• Conditions: Bacterial contamination of antibacterial lens cases when used in conjunction with marketed contact lenses on a daily wear (ie. wearing contact lenses during the day and removing prior to sleep) schedule; Eye - Normal eye development and function

• Registration Number: ACTRN12609000165280
• Lead Sponsor: Institute for Eye Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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
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;
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 beneficial manner;
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;
Allergy or intolerance to silver;
Pregnant women are excluded from the trial - formal testing of pregnancy is not required. A participant's verbal report is sufficient.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess bacterial contamination of antibacterial lens cases when used in conjunction with marketed contact lenses on a daily wear (ie. contact lenses worn during the day and removed prior to sleep) schedule. Used contact lens storage cases will be collected at the end of the clinical trial and transferred to the Institute for Eye Research (IER) microbiology laboratory. Swab samples will be taken from inner surfaces of lens cases for routine microbiology isolation and identification. Contamination rate of used cases will be then determined based on data from microbiological analysis[At 1 month, 3 months and 4 months from the baseline visit]

Secondary Outcome Measures

Name	Time	Method
one[N/A]