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Evaluation of efficacy of moxifloxacin (0.5%) in the treatment of non-perforated bacterial corneal ulcers
ISRCTN ISRCTN10323655
DOI 10.1186/ISRCTN10323655
ClinicalTrials.gov identifier
EudraCT number
Public title Evaluation of efficacy of moxifloxacin (0.5%) in the treatment of non-perforated bacterial corneal ulcers
Scientific title Evaluation of efficacy of moxifloxacin (0.5%) in the treatment of non-perforated bacterial corneal ulcers: a randomised controlled trial
Acronym N/A
Serial number at source OP-19/07.09.2009
Study hypothesis 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.
Lay summary
Ethics approval 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)
Study design Prospective randomised controlled clinical trial
Countries of recruitment India
Disease/condition/study domain Corneal ulcer
Participants - inclusion criteria Non-perforated bacterial corneal ulcers
Participants - exclusion criteria 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
Anticipated start date 01/02/2009
Anticipated end date 01/02/2010
Status of trial Completed
Patient information material Not available in web format, please use contact details below to request a patient information sheet
Target number of participants 150
Interventions 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.
Primary outcome measure(s) 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.
Secondary outcome measure(s) 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.
Sources of funding All India Institute of Medical Sciences (AIIMS) (India)
Trial website
Publications
Contact name Dr  Namrata  Sharma
  Address Rajendra Prasad Centre for Ophthalmic Sciences
All India Institute of Medical Sciences (AIIMS)
Ansari Nagar
  City/town New Delhi
  Zip/Postcode 110029
  Country India
  Tel +91 (0)11 26593144
  Fax +91 (0)11 26588919
  Email namrata103@hotmail.com
Sponsor Rajendra Prasad Centre for Ophthalmic Sciences (India)
  Address All India Institute of Medical Sciences (AIIMS)
Ansari Nagar
  City/town New Delhi
  Zip/Postcode 110029
  Country India
  Tel +91 (0)11 26593101
  Fax +91 (0)11 26588919
  Email namrata103@hotmail.com
  Sponsor website: http://www.aiims.edu/rpcentre.htm
Date applied 30/06/2010
Last edited 09/09/2010
Date ISRCTN assigned 11/08/2010
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