Levofloxacin 1.5% Ophthalmic Drop as Antibiotic Prophylaxis After LASIK or SMILE (CRVT Study)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0011907

Enrollment

Registered

2026-04-27

Start date

2024-12-10

Completion date

Unknown

Last updated

2026-05-04

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

Conditions

None listed

Interventions

Drug : Study Group (Levofloxacin 1.5%) -Drug name: Cravit ophthalmic solution 1.5% (Levofloxacin 15 mg) -Dosage/Frequency: 1 drop per administration, 3 times daily -Duration: 14 days after surgery -Ro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Adults aged 19 to under 50 years. 2)Patients scheduled to undergo LASIK (Laser-Assisted In Situ Keratomileusis) or SMILE (Small Incision Lenticule Extraction) surgery, for whom the researcher deems post-surgery prescription of Levofloxacin or Moxifloxacin necessary. 3)Individuals who have provided written consent to participate in this clinical study.

Exclusion criteria

Exclusion criteria: 1)Individuals who have used cyclosporine, steroids, or antibiotic eye drops within 4 weeks prior to the consent date. 2)Individuals who have used topical antibiotic eye drops within 30 days prior to the consent date. 3)Individuals with ocular inflammation other than Meibomian Gland Dysfunction (MGD) or dry eye. 4)Individuals with severe dry eye (corneal staining score NEI (National Eye Institute) = 4, TBUT (Tear Break Up Time) < 6 seconds). 5)Individuals diagnosed with Sjögren's syndrome. 6)Individuals who have newly used or changed the dosage of systemic immunosuppressants or steroids for local or systemic diseases within 4 weeks prior to the consent date. 7)Individuals who have participated in another clinical study within the last 3 months. 8)Individuals with ocular disorders or conditions that may affect the interpretation of study results, or with a history of active eye infections, suspected or confirmed chronic or recurrent ocular inflammatory diseases, active herpes, vaccinia, varicella, keratoconjunctivitis, ocular tuberculosis, or fungal infections. 9)Individuals with uncontrolled glaucoma or ocular hypertension. 10)Individuals with intraocular pressure exceeding 22 mmHg. 11)Individuals with hypersensitivity to the main or constituent ingredients of the clinical study drug. 12)Pregnant or breastfeeding women, or women planning to become pregnant. 13)Individuals deemed unsuitable for participation in the clinical study by the researcher.

Design outcomes

Primary

Measure	Time frame
Change in corneal staining score between groups,within-group	—

Secondary

Measure	Time frame
Change in corneal staining score between groups,within-group;Within-group and between-group changes in ocular discomfort score;Within-group and between-group changes in tear break-up time (TBUT)	—

Countries

Korea, Republic of

Contacts

Public ContactDongWon Baek

Eyeonce Eye Clinic Gangnam

dongwon84@daum.net+82-2-593-3313

Outcome results