Condition category
Ear, Nose and Throat
Date applied
29/12/2011
Date assigned
10/01/2012
Last edited
04/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The first line of treatment for fungal corneal ulcers in the eye is natamycin eye. Generally such ulcers heal within 2 weeks. If they do not heal in 10-14 days another anti-fungal drug is used, such as voriconazole eye drops. However, the eye drops may not penetrate a deep lesion. Hence the aim of this study is to find out whether the injection of voriconazole into the eye is more effective than addition of another eye drop such as voriconazole in cases not responding to conventional antifungal therapy.

Who can participate?
Patients aged over 18 with fungal corneal ulcers not showing any signs of improvement after two weeks treatment with natamycin eye drops.

What does the study involve?
Participants will be randomly allocated into two groups. One group will be treated with voriconazole eye drops while the other group will be treated with voriconazole injections into the eye.

What are the possible benefits and risks of participating?
The benefits of enrolling are the treatment of the ulcer and the risks are slight pain and perforation of the ulcer. With both voriconazole eye drops and voriconazole injections there may be transient visual hallucinations which are reported rarely.

Where is the study run from?
Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences (India).

When is study starting and how long is it expected to run for?
The study ran from December 2008 to June 2010.

Who is funding the study?
Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences (India).

Who is the main contact?
Namrata Sharma, MD, DNB, MNAMS
namrata103@hotmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Namrata Sharma

ORCID ID

Contact details

Dr Rajendra Prasad Centre for Ophthalmic Sciences
All India Institute of Medical Sciences
Ansari Nagar
New Delhi
110029
India
+91 11 2659 3144
namrata103@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparative evaluation of topical versus intrastromal injection of voriconazole as an adjunct to natamycin in recalcitrant fungal keratitis: a randomised controlled trial

Acronym

Study hypothesis

In cases of fungal keratitis who do not respond to natamycin, voriconazole is usually added. This can be given as topical eye drops or may be given in the form of injection. When injected intra-corneally, i.e. at the site of the lesion as targeted drug delievery , it may be be more effective. In addittion, the problems of compliance with topical eye drops are also addressed here.

Ethics approval

Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences (AIIMS), India, 30/11/2008

Study design

Randomized 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 the contact details below to request a patient information sheet

Condition

Fungal corneal ulcer, fungal keratitis

Intervention

Forty eyes of forty patients randomized into two groups of 20 patients each.

Group 1:
Topical 5% natamycin eye drops 4 hourly, 0.3% ciprofloxacin hydrochloride eye drops four times a day, 2% homatropine eye drops and 1% voriconazole eye drops prepared by ocular pharmacology by reconstituting injection voriconazole 200 mg powder in 19ml ringer lactate to instill 1 hourly round the clock for 48 hours followed by tapering of drug.

Group 2:
Patients randomized to intrastromal injections were taken to the operating room. Injection voriconazole 200mg powder reconstituted with Ringer lactate to obatin 50µg/0.1ml solution.
Injections were repeated 72 hours apart. Patients in this group also received topical therapy with 5% natamycin 4 hourly, cycloplegics and 0.3% ciprofloxacin hydrochloride 6 hourly.

Intervention type

Drug

Phase

Not Applicable

Drug names

Atamycin, voriconazole

Primary outcome measures

Best Spectacle Corrected Visual Acuity (BSCVA) 3 months after intervention.

Secondary outcome measures

Time to healing

Overall trial start date

01/12/2008

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with a smear or culture proven fungal ulcers
2. Ulcers greater than 2mm in size, involving more than one-third of the stromal thickness and not showing any signs of clinical improvement after two weeks of natamycin
3. Patients who were willing to be treated as an inpatient, willing to follow up regularly, and return for medications regularly every 48-72 hours

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Patients with mixed infection on smear or culture, evidence of herpetic keratitis on history or examination, impending perforation, bilateral ulcers, those with vision less than 6/60 in the other eye, pre-existing scar not distinguishable from the new ulcer
2. Those less than 18 years of age

Recruitment start date

01/12/2008

Recruitment end date

30/06/2010

Locations

Countries of recruitment

India

Trial participating centre

Dr Rajendra Prasad Centre for Ophthalmic Sciences
New Delhi
110029
India

Sponsor information

Organisation

Dr Rajendra Prasad Centre for Ophthalmic Sciences (India)

Sponsor details

All India Institute of Medical Sciences
Ansari Nagar
New Delhi
110029
India
+91 11 2659 3144
namrata103@hotmail.com

Sponsor type

Hospital/treatment centre

Website

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

Funders

Funder type

Research organisation

Funder name

Dr Rajendra Prasad Centre for Ophthalmic Sciences (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