ACTRN12608000626369
Completed
Phase 2
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.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CIBA VISION Corporation
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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