Endophthalmitis PostoperativePhase 1/2NCT04212429
The Clinical Safety of Levofloxacin 1.5% vs Topical Moxifloxacin 0.5%
A Phase 1/2 study testing Levofloxacin Ophthalmic Product and Moxifloxacin Ophthalmic Solution in people with Endophthalmitis Postoperative, run by National University of Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endophthalmitis Postoperative
- What is being tested?
- Levofloxacin Ophthalmic Product and Moxifloxacin Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteMalaysia
- Study dates
- 23 Sep 2019to May 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients planned for vitrectomy for macula hole, ERM, RD surgery
- Age 18 and above
- Not on any topical medication
Who cannot join
- Patients with underlying ocular surface disease
- Fluoroquinolone allergy
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
UKM Medical Centre
Cheras, Kuala Lumpur, 56000
Wan Haslina Wan Abdul Halim, M.D(UKM), +6019-6679633, afifiyad@yahoo.co.uk
Wan Haslina Wan Abdul Halim, M.D(UKM)
About this study
Official title: The Clinical Safety of Topical Levofloxacin 1.5% vs Topical Moxifloxacin 0.5%
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.
Read the 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.
- Conditions
- Endophthalmitis Postoperative
- Being tested
- Levofloxacin Ophthalmic Product, Moxifloxacin Ophthalmic Solution
- Keywords
- Clinical Safety, Levofloxacin 1.5%, Moxifloxacin 0.5%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levofloxacin Ophthalmic ProductDrug
Also called Cravit 1.5%
Levofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily for 3 days pre-operatively and one drop on the day of operation.
Moxifloxacin Ophthalmic SolutionDrug
Also called Vigamox 0.5%
Moxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily for 3 days pre-operatively and one drop on the day of operation.
| Study group | Role | What they receive |
|---|---|---|
| Levofloxacin -1 hour group | Active comparator | Levofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 1-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection. Receives: Drug: Levofloxacin Ophthalmic Product |
| Levofloxacin-2 hour group | Active comparator | Levofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 2-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection. Receives: Drug: Levofloxacin Ophthalmic Product |
| Levofloxacin-4 hour group | Active comparator | Levofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 4-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection. Receives: Drug: Levofloxacin Ophthalmic Product |
| Levofloxacin-6 hour group | Active comparator | Levofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 6-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection. Receives: Drug: Levofloxacin Ophthalmic Product |
| Moxifloxacin-1 hour group | Active comparator | Moxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 1-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection. Receives: Drug: Moxifloxacin Ophthalmic Solution |
| Moxifloxacin-2 hour group | Active comparator | Moxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 2-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection. Receives: Drug: Moxifloxacin Ophthalmic Solution |
| Moxifloxacin-4 hour group | Active comparator | Moxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 4-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection. Receives: Drug: Moxifloxacin Ophthalmic Solution |
| Moxifloxacin-6 hour group | Active comparator | Moxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 8-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection. Receives: Drug: Moxifloxacin Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of change in corneal surface in patients treated with topical levofloxacin 1.5% ophthalmic solution and topical moxifloxacin 0.5% ophthalmic solution
Evaluation of non-invasive tear break-up time (NITBUT), redness analysis, tear meniscus height and Tear Break-up Time (TBUT) of corneal surface from Baseline by using Oculus Keratograph-5 Machine at Day 3 of eyedrop instillation. Corneal surface signs (ie punctate epithelial erosions) is also measured by slit-lamp examination and graded using Oxford Scale Eye Grading.
Measured: Day 3 of eyedrop instillation
Comparison of change in corneal surface in patients treated with topical levofloxacin 1.5% ophthalmic solution and topical moxifloxacin 0.5% ophthalmic solution.
Evaluation of non-invasive tear break-up time (NITBUT), redness analysis, tear meniscus height and Tear Break-up Time (TBUT) of corneal surface from Baseline by using Oculus Keratograph-5 Machine at 1-month post operation. Corneal surface signs (ie punctate epithelial erosions) is also measured by slit-lamp examination and graded using Oxford Scale Eye Grading.
Measured: 1-month post operation
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
Change in Concentration of Endothelial cell count (cells/mm2) from Baseline, measured at Day 3 of eyedrop instillation using a non-contact TOPCON Specular Microscopy model SP-1P.
Measured: Day 3 of eyedrop instillation
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
Change in Concentration of Endothelial cell count (cells/mm2) from Baseline, measured at 1-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Measured: 1-month post-operation
Comparison of Endothelial cell morphology in patients treated with topical levofloxacin 1.5% ophthalmic solution and topical moxifloxacin 0.5% ophthalmic solution
Change in Endothelial cell morphology from Baseline by assessing the Polymegathism (CV) which is the variation in individual cell areas, and Pleomorphism which is the increased in variability of cell shape, at Day 3 of eyedrop instillation using a non-contact TOPCON Specular Microscopy model SP-1P.
Measured: Day 3 of eyedrop instillation
Comparison of Endothelial cell morphology in patients treated with topical levofloxacin 1.5% ophthalmic solution and topical moxifloxacin 0.5% ophthalmic solution
Change in Endothelial cell morphology from Baseline by assessing the Polymegathism (CV) which is the variation in individual cell areas, and Pleomorphism which is the increased in variability of cell shape, at 1-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Measured: 1-month post-operation
Secondary outcomes (1)
Side effects
To report any untoward incidence of endophthalmitis during the study period.
Measured: Post-operative period until study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2019
- Study start23 Sep 2019
- Primary completionAug 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Endophthalmitis PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Santen Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Wan Haslina Wan Abdul Halim, National University of Malaysia
- Investigators
- Wan Haslina Wan Abdul Halim, M.D(UKM), Study chair, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212429
- Sponsor's protocol ID
- FF-2019-320
- Status last verified
- Dec 2019
- First submitted
- 10 Dec 2019
- Last updated
- 14 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jackson TL, Paraskevopoulos T, Georgalas I. Systematic review of 342 cases of endogenous bacterial endophthalmitis. Surv Ophthalmol. 2014 Nov-Dec;59(6):627-35. doi: 10.1016/j.survophthal.2014.06.002. Epub 2014 Jun 18.
PubMed 25113611Nishida T, Ishida K, Niwa Y, Kawakami H, Mochizuki K, Ohkusu K. An eleven-year retrospective study of endogenous bacterial endophthalmitis. J Ophthalmol. 2015;2015:261310. doi: 10.1155/2015/261310. Epub 2015 Jan 31.
PubMed 25802752Kernt M, Kampik A. Endophthalmitis: Pathogenesis, clinical presentation, management, and perspectives. Clin Ophthalmol. 2010 Mar 24;4:121-35. doi: 10.2147/opth.s6461.
PubMed 20390032Puustjarvi T, Terasvirta M, Nurmenniemi P, Lokkila J, Uusitalo H. Penetration of topically applied levofloxacin 0.5% and ofloxacin 0.3% into the vitreous of the non-inflamed human eye. Graefes Arch Clin Exp Ophthalmol. 2006 Dec;244(12):1633-7. doi: 10.1007/s00417-006-0360-0.
PubMed 16715252Hariprasad SM, Blinder KJ, Shah GK, Apte RS, Rosenblatt B, Holekamp NM, Thomas MA, Mieler WF, Chi J, Prince RA. Penetration pharmacokinetics of topically administered 0.5% moxifloxacin ophthalmic solution in human aqueous and vitreous. Arch Ophthalmol. 2005 Jan;123(1):39-44. doi: 10.1001/archopht.123.1.39.
PubMed 15642810Robertson SM, Curtis MA, Schlech BA, Rusinko A, Owen GR, Dembinska O, Liao J, Dahlin DC. Ocular pharmacokinetics of moxifloxacin after topical treatment of animals and humans. Surv Ophthalmol. 2005 Nov;50 Suppl 1:S32-45. doi: 10.1016/j.survophthal.2005.07.001.
PubMed 16257309Bucci FA Jr, Nguimfack IT, Fluet AT. Pharmacokinetics and aqueous humor penetration of levofloxacin 1.5% and moxifloxacin 0.5% in patients undergoing cataract surgery. Clin Ophthalmol. 2016 May 2;10:783-9. doi: 10.2147/OPTH.S91286. eCollection 2016.
PubMed 27194905Jackson MA, Schutze GE; COMMITTEE ON INFECTIOUS DISEASES. The Use of Systemic and Topical Fluoroquinolones. Pediatrics. 2016 Nov;138(5):e20162706. doi: 10.1542/peds.2016-2706.
PubMed 27940800Watanabe R, Nakazawa T, Yokokura S, Kubota A, Kubota H, Nishida K. Fluoroquinolone antibacterial eye drops: effects on normal human corneal epithelium, stroma, and endothelium. Clin Ophthalmol. 2010 Oct 21;4:1181-7. doi: 10.2147/OPTH.S13672.
PubMed 21060669Hanscom TA. Postoperative endophthalmitis. Clin Infect Dis. 2004 Feb 15;38(4):542-6. doi: 10.1086/381262. Epub 2004 Jan 26.
PubMed 14765348
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Safety of Topical Levofloxacin 1.5% vs Topical Moxifloxacin 0.5%
- ClinicalTrials.gov ID
- NCT04212429
- Acronym / sponsor ID
- FF-2019-320
- Conditions
- Endophthalmitis Postoperative
- Keywords
- Clinical Safety, Levofloxacin 1.5%, Moxifloxacin 0.5%
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- Santen Pharmaceutical Co., Ltd.
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 27 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- 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.
| Arm | Type | Receives |
|---|---|---|
| Levofloxacin -1 hour group | Active comparator | Drug: Levofloxacin Ophthalmic ProductLevofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 1-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection. |
| Levofloxacin-2 hour group | Active comparator | Drug: Levofloxacin Ophthalmic ProductLevofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 2-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection. |
| Levofloxacin-4 hour group | Active comparator | Drug: Levofloxacin Ophthalmic ProductLevofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 4-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection. |
| Levofloxacin-6 hour group | Active comparator | Drug: Levofloxacin Ophthalmic ProductLevofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 6-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection. |
| Moxifloxacin-1 hour group | Active comparator | Drug: Moxifloxacin Ophthalmic SolutionMoxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 1-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection. |
| Moxifloxacin-2 hour group | Active comparator | Drug: Moxifloxacin Ophthalmic SolutionMoxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 2-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection. |
| Moxifloxacin-4 hour group | Active comparator | Drug: Moxifloxacin Ophthalmic SolutionMoxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 4-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection. |
| Moxifloxacin-6 hour group | Active comparator | Drug: Moxifloxacin Ophthalmic SolutionMoxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 8-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients planned for vitrectomy for macula hole, ERM, RD surgery
- Age 18 and above
- Not on any topical medication
Key exclusion criteria (2 listed)
- Patients with underlying ocular surface disease
- Fluoroquinolone allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levofloxacin Ophthalmic ProductAlso: Cravit 1.5%Levofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily for 3 days pre-operatively and one drop on the day of operation. | Drug | Levofloxacin -1 hour group, Levofloxacin-2 hour group, Levofloxacin-4 hour group, Levofloxacin-6 hour group |
| Moxifloxacin Ophthalmic SolutionAlso: Vigamox 0.5%Moxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily for 3 days pre-operatively and one drop on the day of operation. | Drug | Moxifloxacin-1 hour group, Moxifloxacin-2 hour group, Moxifloxacin-4 hour group, Moxifloxacin-6 hour group |
Primary outcome
Comparison of change in corneal surface in patients treated with topical levofloxacin 1.5% ophthalmic solution and topical moxifloxacin 0.5% ophthalmic solution
Time frame: Day 3 of eyedrop instillation
Evaluation of non-invasive tear break-up time (NITBUT), redness analysis, tear meniscus height and Tear Break-up Time (TBUT) of corneal surface from Baseline by using Oculus Keratograph-5 Machine at Day 3 of eyedrop instillation. Corneal surface signs (ie punctate epithelial erosions) is also measured by slit-lamp examination and graded using Oxford Scale Eye Grading.
Comparison of change in corneal surface in patients treated with topical levofloxacin 1.5% ophthalmic solution and topical moxifloxacin 0.5% ophthalmic solution.
Time frame: 1-month post operation
Evaluation of non-invasive tear break-up time (NITBUT), redness analysis, tear meniscus height and Tear Break-up Time (TBUT) of corneal surface from Baseline by using Oculus Keratograph-5 Machine at 1-month post operation. Corneal surface signs (ie punctate epithelial erosions) is also measured by slit-lamp examination and graded using Oxford Scale Eye Grading.
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
Time frame: Day 3 of eyedrop instillation
Change in Concentration of Endothelial cell count (cells/mm2) from Baseline, measured at Day 3 of eyedrop instillation using a non-contact TOPCON Specular Microscopy model SP-1P.
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
Time frame: 1-month post-operation
Change in Concentration of Endothelial cell count (cells/mm2) from Baseline, measured at 1-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Comparison of Endothelial cell morphology in patients treated with topical levofloxacin 1.5% ophthalmic solution and topical moxifloxacin 0.5% ophthalmic solution
Time frame: Day 3 of eyedrop instillation
Change in Endothelial cell morphology from Baseline by assessing the Polymegathism (CV) which is the variation in individual cell areas, and Pleomorphism which is the increased in variability of cell shape, at Day 3 of eyedrop instillation using a non-contact TOPCON Specular Microscopy model SP-1P.
Comparison of Endothelial cell morphology in patients treated with topical levofloxacin 1.5% ophthalmic solution and topical moxifloxacin 0.5% ophthalmic solution
Time frame: 1-month post-operation
Change in Endothelial cell morphology from Baseline by assessing the Polymegathism (CV) which is the variation in individual cell areas, and Pleomorphism which is the increased in variability of cell shape, at 1-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
1 secondary outcome
Side effects
Time frame: Post-operative period until study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 25113611Jackson TL, Paraskevopoulos T, Georgalas I. Systematic review of 342 cases of endogenous bacterial endophthalmitis. Surv Ophthalmol. 2014 Nov-Dec;59(6):627-35. doi: 10.1016/j.survophthal.2014.06.002. Epub 2014 Jun 18.
- Background: PubMed 25802752Nishida T, Ishida K, Niwa Y, Kawakami H, Mochizuki K, Ohkusu K. An eleven-year retrospective study of endogenous bacterial endophthalmitis. J Ophthalmol. 2015;2015:261310. doi: 10.1155/2015/261310. Epub 2015 Jan 31.
- Background: PubMed 20390032Kernt M, Kampik A. Endophthalmitis: Pathogenesis, clinical presentation, management, and perspectives. Clin Ophthalmol. 2010 Mar 24;4:121-35. doi: 10.2147/opth.s6461.
- Background: PubMed 16715252Puustjarvi T, Terasvirta M, Nurmenniemi P, Lokkila J, Uusitalo H. Penetration of topically applied levofloxacin 0.5% and ofloxacin 0.3% into the vitreous of the non-inflamed human eye. Graefes Arch Clin Exp Ophthalmol. 2006 Dec;244(12):1633-7. doi: 10.1007/s00417-006-0360-0.
- Results publication: PubMed 15642810Hariprasad SM, Blinder KJ, Shah GK, Apte RS, Rosenblatt B, Holekamp NM, Thomas MA, Mieler WF, Chi J, Prince RA. Penetration pharmacokinetics of topically administered 0.5% moxifloxacin ophthalmic solution in human aqueous and vitreous. Arch Ophthalmol. 2005 Jan;123(1):39-44. doi: 10.1001/archopht.123.1.39.
- Results publication: PubMed 16257309Robertson SM, Curtis MA, Schlech BA, Rusinko A, Owen GR, Dembinska O, Liao J, Dahlin DC. Ocular pharmacokinetics of moxifloxacin after topical treatment of animals and humans. Surv Ophthalmol. 2005 Nov;50 Suppl 1:S32-45. doi: 10.1016/j.survophthal.2005.07.001.
- Results publication: PubMed 27194905Bucci FA Jr, Nguimfack IT, Fluet AT. Pharmacokinetics and aqueous humor penetration of levofloxacin 1.5% and moxifloxacin 0.5% in patients undergoing cataract surgery. Clin Ophthalmol. 2016 May 2;10:783-9. doi: 10.2147/OPTH.S91286. eCollection 2016.
- Results publication: PubMed 27940800Jackson MA, Schutze GE; COMMITTEE ON INFECTIOUS DISEASES. The Use of Systemic and Topical Fluoroquinolones. Pediatrics. 2016 Nov;138(5):e20162706. doi: 10.1542/peds.2016-2706.
- Results publication: PubMed 21060669Watanabe R, Nakazawa T, Yokokura S, Kubota A, Kubota H, Nishida K. Fluoroquinolone antibacterial eye drops: effects on normal human corneal epithelium, stroma, and endothelium. Clin Ophthalmol. 2010 Oct 21;4:1181-7. doi: 10.2147/OPTH.S13672.
- Results publication: PubMed 14765348Hanscom TA. Postoperative endophthalmitis. Clin Infect Dis. 2004 Feb 15;38(4):542-6. doi: 10.1086/381262. Epub 2004 Jan 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wan Haslina Wan Abdul Halim, M.D(UKM) study chair
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Levofloxacin Ophthalmic Product and Moxifloxacin Ophthalmic Solution in people with Endophthalmitis Postoperative, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wan Haslina Wan Abdul Halim, M.D(UKM) (+6019-6679633, afifiyad@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of change in corneal surface in patients treated with topical levofloxacin 1.5% ophthalmic solution and topical moxifloxacin 0.5% ophthalmic solution (time frame: Day 3 of eyedrop instillation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04212429, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.