Antibiotic drop instillation during continuous contact lens wear.

A pilot, prospective, open label, randomised, controlled, parallel design, three-month clinical trial to assess the safety of twice daily instillation of antibiotic versus saline drops during bilateral continuous wear of marketed contact lenses in experienced wearers.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000626369

Enrollment

Registered

2008-12-12

Start date

2009-01-05

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 this pilot trial is to assess the safety of antibiotic drop instillation compared to a control group using saline drops instead of antibiotic during continuous lens wear.

Interventions

Twice daily instillation of TOBREX (tobramycin 0.3%) antibiotics drops (two drops on waking and two drops prior to sleep each night) during continuous lens wear compared to a control group using saline drops over a three month period

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

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 Snellen Visual Acuity of 6/12 (metres) or better in each eye with contact lenses, which means the participant can read within 3 lines of the nominal performance for human distance visiion (i.e. 6/6). Be experienced at wearing contact lenses

Exclusion criteria

Pre-existing ocular irritation that would preclude contact lens fitting; Had eye surgery or any systemic or ocular medication within 12 weeks immediately prior to enrolment for this trial; Undergone corneal refractive surgery; Worn RGP’s or orthokeratology lenses within the previous two weeks; Contraindications to hydrogel contact lens wear; Contraindication / allergy to tobramycin; Be currently enrolled in another clinical trial or have participated in a clinical trial within the previous two weeks. Females are excluded from the trial

Outcome results