Clinical trial NCT04212429: The Clinical Safety of Levofloxacin 1.5% vs Topical Moxifloxacin 0.5%
Official title: The Clinical Safety of Topical Levofloxacin 1.5% vs Topical Moxifloxacin 0.5%
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Endophthalmitis Postoperative
Keywords: Clinical Safety
Levofloxacin 1.5%
Moxifloxacin 0.5%
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
Collaborators: name: Santen Pharmaceutical Co., Ltd.
First posted: 2019-12-27
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The qualified patients will be randomized on a 1:1 ratio into each treatment arm. Qualified eyes were further randomized into one of four subgroups, which specified the time between the last drop of study medication and the time of aqueous and vitreous humor sample collection (i.e., 1-, 2-, 4-, and 6-hour subgroups- about 32 patients per subgroup. Within each subgroups, there will be 16 of Levofloxacin group and 16 of Moxifloxacin group.
Primary purpose: PREVENTION

Brief summary: Endophthalmitis is defined as intraocular inflammatory disorder affecting the vitreous cavity that can result from exogenous or endogenous spread of infecting organisms into the eye. Patients presents with reduced or blurred vision, red eye, pain, and lid swelling.

Endophthalmitis can progress into panophthalmitis, corneal infiltration and perforation, and finally phthisis bulbi. For exogenous endopthalmitis, the intraocular inflammation occurs due to a breach of the ocular compartment. The infectious agent indirectly introduced into the eye. This usually happens after intraocular surgery such as cataract surgery, vitrectomy, glaucoma filtration surgery, intravitreal injections, and other causes include penetrating ocular trauma or from adjacent periocular tissue. Several prophylactic measures have been taken to reduce the incidence of post-operative endopthalmitis postcataract surgery, this includes the use of pre-operative topical levofloxacin, intrameral cefuroxime, and providone iodine as ocular surface preparation.The proposed study is to evaluate clinical safety of Levofloxacin 1.5% and Moxifloxacin 0.5% on the anterior segment parameters.

Detailed description: This is a prospective, double - blinded randomized clinical trial conducted in University Kebangsaan Malaysia Medical Centre (UKMMC) where there are two intervention arms. All patients from Ophthalmology Clinic in UKM Medical Centre from September 2019 till December 2021 will be involved in this study. Patients who fulfill the inclusion criteria will be included in this study. All eligible subjects will be asked to sign an informed consent.

The qualified patients will be randomized on a 1:1 ratio into each treatment arm. Qualified eyes were further randomized into one of four subgroups, which specified the time between the last drop of study medication and the time of aqueous and vitreous humor sample collection (i.e., 1-, 2-, 4-, and 6-hour subgroups- about 32 patients per subgroup-: 16 Levofloxacin, 16 Moxifloxacin.

Patient will undergo clinical assessment at the outpatient Ophthalmology Clinic at UKMMC. Initially, a non-contact assessment of the corneal surface will be done by the Keratograph 5. The parameters recorded are non-invasive tear break up time (NITBUT), tear film properties and redness analysis. The endothelial cell count will be analysed with a specular microscopy. Subsequently, patient will be assessed by a blinded ophthalmologist for clinical evaluation of corneal surface which includes tear break up time (TBUT), ocular surface abnormality and Rose-bengal staining. During the first visit, each patient will be educated on proper instillation of the eye drops to ensure the proper dose is administered. A prior observation of self- instillation of the eye drop by the study staff is required.

For 3 days prior to the day of the elective vitrectomy surgery, subjects will instill exactly one drop of study medication into their operative eye four times daily. On the day of surgery (visit 2, day 4), patients will receive their final drop of study medication administered by trained study personnel at the study site.

Post-vitrectomy, patients will be continued on the specified antibiotics for 4 hourly for 2 weeks. Then the antibiotic will taper down to 6 hourly (QID) daily for 1 week and antibiotics will be discontinued after that. Corneal safety will be assessed at 1 week and 4 weeks post operatively.

Eligibility criteria: Inclusion Criteria:

* All patients planned for vitrectomy for macula hole, ERM, RD surgery
* Age 18 and above
* Not on any topical medication

Exclusion Criteria:

* Patients with underlying ocular surface disease
* Fluoroquinolone allergy

Primary outcomes:
measure: Comparison of change in corneal surface in patients treated with topical levofloxacin 1.5% ophthalmic solution and topical moxifloxacin 0.5% ophthalmic solution
timeFrame: Day 3 of eyedrop instillation
measure: Comparison of change in corneal surface in patients treated with topical levofloxacin 1.5% ophthalmic solution and topical moxifloxacin 0.5% ophthalmic solution.
timeFrame: 1-month post operation
measure: Comparison of Concentration of Endothelial cell count (cells/mm2) in patients treated with topical levofloxacin 1.5% ophthalmic solution and topical moxifloxacin 0.5% ophthalmic solution
timeFrame: Day 3 of eyedrop instillation
measure: Comparison of Concentration of Endothelial cell count (cells/mm2) in patients treated with topical levofloxacin 1.5% ophthalmic solution and topical moxifloxacin 0.5% ophthalmic solution
timeFrame: 1-month post-operation
measure: Comparison of Endothelial cell morphology in patients treated with topical levofloxacin 1.5% ophthalmic solution and topical moxifloxacin 0.5% ophthalmic solution
timeFrame: Day 3 of eyedrop instillation
measure: Comparison of Endothelial cell morphology in patients treated with topical levofloxacin 1.5% ophthalmic solution and topical moxifloxacin 0.5% ophthalmic solution
timeFrame: 1-month post-operation
Secondary outcomes:
measure: Side effects
timeFrame: Post-operative period until study completion, an average of 2 years
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: UKM Medical Centre
state: Kuala Lumpur
Study officials:
affiliation: National University of Malaysia
name: Wan Haslina Wan Abdul Halim, M.D(UKM)
role: STUDY_CHAIR
References:
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