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Bacterial adhesion to unworn and worn silicone hydrogel lenses

A prospective, randomised, cross over, open label, bilateral design clinical trial to investigate the differences in the adhesion of various bacteria to a range of silicone hydrogel contact lenses worn by experienced contact lens wearers and to determine whether lens wear modulates adhesion

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000230257
Enrollment
30
Registered
2009-05-08
Start date
2009-02-01
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 differences in the adhesion of various microorganisms on various silicone hydrogel lens materials and to determine whether lens wear modulates this adhesion.

Interventions

Nine silicone hydrogel lenses (Acuvue Advance, Acuvue Oasys, Acuvue Trueye, Night and Day, Air Optix Aqua, Biofinity, Avaira, Purevision, PremiO) will be tested. Each lens type will be worn by participants on a daily replacement schedule for approximately two weeks with a one day wash out between lens types. A minimum of 3 worn lenses will be collected for each lens type from each participant for bacterial adhesion testing.

Sponsors

Institute for Eye Reseach
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026