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ISRCTN
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ISRCTN10323655
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ClinicalTrials.gov identifier
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Public title
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Evaluation of efficacy of moxifloxacin (0.5%) in the treatment of non-perforated bacterial corneal ulcers
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Scientific title
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Evaluation of efficacy of moxifloxacin (0.5%) in the treatment of non-perforated bacterial corneal ulcers: a randomised controlled trial
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Acronym
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N/A
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Serial number at source
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OP-19/07.09.2009
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Study hypothesis
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The use of fortified intensive antibiotics has practical limitations related to availability and cost. The effectiveness of multiple fortified antibiotics is limited further by variability in shelf life and the dissipation of 1 agent if a second agent is applied shortly thereafter. The use of multiple antibiotics simultaneously and with frequent dosing may result in added toxicity and damage to the ocular surface epithelium, thereby impairing recovery.
Fluoroquinolones offer the advantages of good ocular penetration, demonstration of broad-spectrum efficacy, excellent safety profiles in ocular infections, and a distinct mode of resistance acquisition.
Moxifloxacin is a fourth-generation fluoroquinolone that exhibits a broad spectrum of bactericidal activity against both Gram-positive and Gram- negative bacterial pathogens, including staphylococci, S. pneumoniae, members of the family enterobacteriaceae, P. aeruginosa, H. influenzae, and Moraxella species. Moxifloxacin has also been shown to have superior activity compared with ciprofloxacin against quinolone resistant strains of S. aureus. Data also shows superior corneal and aqueous penetration of moxifloxacin and so higher therapeutic levels can be obtained, which should lead to more effective antimicrobials activity and hence better clinical outcomes.
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Lay summary
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Ethics approval
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The All India Institute of Medical Sciences Ethics Committee approved on the 4th August 2009 (ref: P-09/2.03.2009 & AA-04/04.08.2009)
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Study design
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Prospective randomised controlled clinical trial
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Countries of recruitment
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India
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Disease/condition/study domain
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Corneal ulcer
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Participants - inclusion criteria
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Non-perforated bacterial corneal ulcers
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Participants - exclusion criteria
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1. Known allergy to fluoroquinolones, aminoglycosides, penicillins,cephalosporins or benzalkoniun chloride
2. Patients with fungal, viral or acanthamoeba infection
3. Patients to be treated with subconjuctival injection(s) of antibiotic(s) and/or with systemic antimicrobials
4. Patients aged 16 - 65 years
5. Pregnant and lactating females
6. Any adverse effects or protocol violations
7. Perforated corneal ulcers
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Anticipated start date
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01/02/2009
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Anticipated end date
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01/02/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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150
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Interventions
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Drug instillation protocol:
1. First 48 hours: 1 drop hourly, day and night
2. Day 3: 1 drop hourly by daya and every 2 hours at night
3. Days 4 - 5: 1 drop every 2 hours by day and every 4 hours by night
4. Days 6 - 7: 1 drop every 4 hours
5. Weeks 2 - 8: 1 drop every 6 hours and stopped when clinically appropriate
The total duration of treatment will be 8 weeks. Additional supportive treatment included vitamins, cycloplegic and antiglaucoma therapy if required. Any change of protocol, adverse event and surgical intervention was documented.
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Primary outcome measure(s)
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1. Time to epithelialisation
2. Time to resolution of the infiltrates
All outcomes were measured on days 2, 4, 7, 14, 21 and at 3 months.
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Secondary outcome measure(s)
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1. Uncorrected Visual Acuity (UCVA)
2. Best Corrected Visual Acuity (BCVA)
All outcomes were measured on days 2, 4, 7, 14, 21 and at 3 months.
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Sources of funding
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All India Institute of Medical Sciences (AIIMS) (India)
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Trial website
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Publications
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Contact name
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Dr
Namrata
Sharma
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Address
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Rajendra Prasad Centre for Ophthalmic Sciences
All India Institute of Medical Sciences (AIIMS)
Ansari Nagar
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City/town
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New Delhi
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Zip/Postcode
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110029
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Country
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India
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Tel
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+91 (0)11 26593144
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Fax
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+91 (0)11 26588919
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Email
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namrata103@hotmail.com
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Sponsor
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Rajendra Prasad Centre for Ophthalmic Sciences (India)
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Address
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All India Institute of Medical Sciences (AIIMS)
Ansari Nagar
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City/town
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New Delhi
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Zip/Postcode
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110029
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Country
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India
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Tel
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+91 (0)11 26593101
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Fax
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+91 (0)11 26588919
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Email
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namrata103@hotmail.com
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Sponsor website:
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http://www.aiims.edu/rpcentre.htm
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Date applied
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30/06/2010
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Last edited
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09/09/2010
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Date ISRCTN assigned
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11/08/2010
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