Daily morning replacement of contact lenses during extended wear by inexperienced contact lens wearers as a means of reducing contact lens related adverse events.

Evaluation of the effectiveness of daily morning contact lens replacement during extended wear as a means of reducing contact lens related ocular adverse events.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000220268

Enrollment

Registered

2009-05-01

Start date

2009-05-01

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

The objective of the trial is to reduce the incidence of microbial keratitis and other ocular adverse responses related to extended contact lens wear. The hypothesis is that regular lens replacement during extended wear exposes the eye to a clean lens surface thereby reducing bacterial build-up on the lens surface resulting in less bacterially-driven ocular adverse events.

Interventions

To determine if daily (morning) replacement of contact lenses during extended wear reduces contact lens related adverse events compared to adverse event rates in historical control trials. Worn lenses are to be removed and discarded within 1 hour of waking each day and new lenses inserted immediately afterwards, for the duration of the study (i.e. 1 month).

Study design

Allocation

Non-randomised trial

Intervention model

Single group

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 vision correctable to at least 6/12 (20/40) or better in each eye with contact lenses; Be inexperienced at wearing contact lenses

Exclusion criteria

Pre-existing ocular irritation that would preclude contact lens fitting; Had eye surgery within 12 weeks immediately prior to enrollment for this trial; Undergone corneal refractive surgery; Contraindications to soft contact lens wear; Be currently enrolled in another clinical tria; or have participated in a clinical trial within the previous two weeks; Pregnant or lactating women not able to complete the study (Investigator discretion)

Outcome results