Antibiotic drop efficacy trial
A proof-of-principle, prospective, open label, randomised, controlled, parallel design, one-month clinical trial to determine if prophylactic instillation of antibiotic drops during continuous wear of silicone hydrogel contact lenses reduces the incidence of contact lens related ocular inflammatory adverse events.
Brien Holden Vision Institute
240 participants
Nov 1, 2010
Interventional
Conditions
Summary
The objective of this proff of principle trial is to determine if prophylactic antibiotic drop used during continuous wear of silicone hydrogel contact lenses reduces the incidence of contact lens related inflammatory ocular adverse events.
Eligibility
Inclusion Criteria6
- Be able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent,
- Be male and 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 / spectacles,
- Have vision correctable to at least 6/12 (20/40) or better in each eye with contact lenses / spectacles,
- Be experienced or may be inexperienced at wearing contact lenses
Exclusion Criteria7
- Any pre-existing ocular irritation, injury or condition that would preclude contact lens fitting,
- Had eye surgery within 12 weeks immediately prior to enrolment for this trial,
- Undergone previous corneal refractive surgery,
- Contraindications to contact lens wear,
- Allergy or intolerance to moxifloxacin or other quinolones/fluoroquinolones,
- Be currently enrolled in another clinical trial or participation in a clinical trial within the previous 2 weeks for longer-term studies and 48 hours between short-term studies,
- Female are excluded from this trial
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Interventions
Test group will be randomised to instil Moxifloxacin antibiotic drops twice a day into each eye on waking and prior to sleep (in the evening). Commercially available siliconhydrogel lenses are to be worn on a continuous wear basis (that is, during the day and night) for approximately I month
Locations(1)
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ACTRN12610000920099