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Ophthalmic preoperative sterilization study of 1.5% LVFX ophthalmic solution

Clinical evaluation of 1.5% Levofloxacin ophthalmic solution in ophthalmic preoperative sterilization

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1080221649
Enrollment
100
Registered
2011-11-11
Start date
2011-11-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ophthalmic preoperative sterilization

Interventions

investigational material(s) Generic name etc : 1.5% Levofloxacin ophthalmic solution INN of investigational material : Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administrat

Sponsors

SANTEN PHARMACEUTICAL CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - 20 years or older at the time of acquisition of the informed consent - those who are scheduled for cataract surgery

Exclusion criteria

Exclusion criteria: - those with a history of serious adverse reaction including hypersensitivity to fluoroquinolone - those judged by the investigator to be otherwise inappropriate as subjects

Design outcomes

Primary

MeasureTime frame
Preoperative sterilization rate Culture-negative conversion rate in the conjunctival sac by the preoperative instillation of 1.5% Levofloxacin ophthalmic solution

Secondary

MeasureTime frame
postoperative non-bacterial rate Culture-negative conversion rate in the conjunctival sac by the postoperative instillation of 1.5% Levofloxacin ophthalmic solution

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026