Trials / Withdrawn
WithdrawnNCT05441930
A Study of Levofloxacin Ocular Implant in Patients Undergoing Routine Bilateral Cataract Surgery
An Interventional, Open Label, Controlled, Randomized, Pairwise, Phase Ib Safety, Tolerability and Pharmacokinetic (PK) Study of Levofloxacin Ocular Implant in Patients Undergoing Routine Bilateral Cataract Surgery
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- PolyActiva Pty Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Open label controlled interventional study in eyes in up to 12 subjects (24 eyes) scheduled for uncomplicated bilateral cataract surgery on separate days.
Detailed description
This is a multicenter, open label, controlled, pairwise, interventional study in eyes in up to 12 subjects (24 eyes) scheduled for uncomplicated bilateral cataract surgery on separate days. Eligible individuals provide informed consent; and are screened for inclusion in the study. Once eligible, subject eyes will be randomized to determine which eye will receive the first surgery. After the first surgery, study participants will receive the control treatment consisting of commercially available topical medications. For the second cataract surgery, study participants will receive a single Levofloxacin Ocular Implant in the posterior sulcus in the surgical eye at the end of cataract surgery. No sham dosing will be conducted in the eyes in the control arm.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Levofloxacin Ocular Implant | Levofloxacin Ocular Implant an implant that delivers a bolus dose of levofloxacin and a constant daily dose for a further 5-7 days. |
| DRUG | Control | Commercially available topical medications as per LEVO-CS102 Surgical Therapy Procedure. |
Timeline
- Start date
- 2023-06-23
- Primary completion
- 2023-12-15
- Completion
- 2024-03-14
- First posted
- 2022-07-01
- Last updated
- 2024-04-12
Locations
3 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05441930. Inclusion in this directory is not an endorsement.