Contact information
Type
Scientific
Primary contact
Dr Namrata Sharma
ORCID ID
Contact details
Rajendra Prasad Centre for Ophthalmic Sciences
All India Institute of Medical Sciences (AIIMS)
Ansari Nagar
New Delhi
110029
India
+91 (0)11 26593144
namrata103@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
OP-19/07.09.2009
Study information
Scientific title
Evaluation of efficacy of moxifloxacin (0.5%) in the treatment of non-perforated bacterial corneal ulcers: a randomised controlled trial
Acronym
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Corneal ulcer
Intervention
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.
Intervention type
Drug
Phase
Phase III
Drug names
Moxifloxacin
Primary outcome measures
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 measures
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.
Overall trial start date
01/02/2009
Overall trial end date
01/02/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Non-perforated bacterial corneal ulcers
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
150
Participant 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
Recruitment start date
01/02/2009
Recruitment end date
01/02/2010
Locations
Countries of recruitment
India
Trial participating centre
Rajendra Prasad Centre for Ophthalmic Sciences
New Delhi
110029
India
Sponsor information
Organisation
Rajendra Prasad Centre for Ophthalmic Sciences (India)
Sponsor details
All India Institute of Medical Sciences (AIIMS)
Ansari Nagar
New Delhi
110029
India
+91 (0)11 26593101
namrata103@hotmail.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
All India Institute of Medical Sciences (AIIMS) (India)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary