Evaluation of efficacy of moxifloxacin (0.5%) in the treatment of non-perforated bacterial corneal ulcers
| ISRCTN | ISRCTN10323655 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10323655 |
| Secondary identifying numbers | OP-19/07.09.2009 |
- Submission date
- 30/06/2010
- Registration date
- 11/08/2010
- Last edited
- 09/09/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Namrata Sharma
Scientific
Scientific
Rajendra Prasad Centre for Ophthalmic Sciences
All India Institute of Medical Sciences (AIIMS)
Ansari Nagar
New Delhi
110029
India
| Phone | +91 (0)11 26593144 |
|---|---|
| namrata103@hotmail.com |
Study information
| Study design | Prospective randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Evaluation of efficacy of moxifloxacin (0.5%) in the treatment of non-perforated bacterial corneal ulcers: a randomised controlled trial |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Moxifloxacin |
| Primary outcome measure | 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 study start date | 01/02/2009 |
| Completion date | 01/02/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | Non-perforated bacterial corneal ulcers |
| Key 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 |
| Date of first enrolment | 01/02/2009 |
| Date of final enrolment | 01/02/2010 |
Locations
Countries of recruitment
- India
Study participating centre
Rajendra Prasad Centre for Ophthalmic Sciences
New Delhi
110029
India
110029
India
Sponsor information
Rajendra Prasad Centre for Ophthalmic Sciences (India)
Hospital/treatment centre
Hospital/treatment centre
All India Institute of Medical Sciences (AIIMS)
Ansari Nagar
New Delhi
110029
India
| Phone | +91 (0)11 26593101 |
|---|---|
| namrata103@hotmail.com | |
| Website | http://www.aiims.edu/rpcentre.htm |
"ROR" |
https://ror.org/02dwcqs71 |
Funders
Funder type
Research organisation
All India Institute of Medical Sciences (AIIMS) (India)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
