Condition category
Eye Diseases
Date applied
30/06/2010
Date assigned
11/08/2010
Last edited
09/09/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.aiims.edu/rpcentre.htm

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

Publication citations

Additional files

Editorial Notes