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Effect of lens wear on bacterial adhesion to lens surfaces

A prospective, randomised, open label, parallel group, cross-over design clinical trial to investigate protein and lipid deposition that mediate bacterial adhesion on the surface of silicone hydrogel contact lenses with use of different lens care solutions during daily and extended wear.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000557336
Acronym
Effect of lens wear on bacterial adhesion to lens surfaces
Enrollment
60
Registered
2008-11-07
Start date
2008-10-31
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 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.

Interventions

Lens care solution crossover during 2 months daily wear (i.e. wear lenses during the day and remove lenses prior to sleep) of silicone hydrogel lenses. 1 month extended wear (continuous wear during the day and night) of silicone hydrogel lenses. There is a 1 calender day washout between treatments. At start of daily wear, each group will be randomly assigned to use either Optifree-Replenish (Alcon, USA) or Menicare Soft (Menicon, Japan) lens care solution. After one month daily wear, subjects wi

Lens care solution crossover during 2 months daily wear (i.e. wear lenses during the day and remove lenses prior to sleep) of silicone hydrogel lenses. 1 month extended wear (continuous wear during the day and night) of silicone hydrogel lenses. There is a 1 calender day washout between treatments. At start of daily wear, each group will be randomly assigned to use either Optifree-Replenish (Alcon, USA) or Menicare Soft (Menicon, Japan) lens care solution. After one month daily wear, subjects will be dispensed with the alternate lens care solution. Subjects will continue with this solution for the duration of the trial (i.e. one further month of daily lens wear and 1 month of extended lens wear).

Sponsors

Institute for Eye Research
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; 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).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026