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September’ 2013 EDITION 3

Entod Research Cell Ltd. (UK) Op's ha ti hd an lI m g icni Es xa c pew ro tih seS «»

Lacrimal Sac Leavage with India’s First

Terminally Sterilised Pre-Filled Syringe Moxifloxacin

September’ 13 EDITION 3

PFS(Moxifloxacin 0.5%)

1ml

ILF LE ER DP

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Terminally

Sterilized by

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* F

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Use

By

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al P

rofe

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nals

Only

India’s First Intraoperative Moxifloxacin Syringe

Purpose:

To evaluate the efficacy of Lacrimal Sac Leavage with

Moxifloxacin0.5% ophthalmic Solution (4 Quin™ PFS

prefilled syringe, Entod Pharmaceuticals Ltd. [India])

0.5% as treatment of Canaliculitis / Dacryocystitis.

Design:

This is a parallel randomized interventional study to evaluate

the efficacy of Lacrimal Sac Leavage with Moxifloxacin 0.5%

ophthalmic Solution as treatment of Canaliculitis/

Dacryocystitis.

Introduction:

Dacryocystitis:

Inflammation of the nasolacrimal sac frequently caused by

nasolacrimal ductobstruction or infection Greek dákryon

(tear) cysta (sac), and –it is (inflammation).

Dacryocystitis may be classified as acute, sub-acute, or

chronic. It may be localized in the sac, extended to include a

pericystitis, or progressed to orbital cellulitis.

Clinical features:

• Pain, swelling, redness over the lacrimal sac

enlargement at medial canthus.ENTOD RESEARCH CELL LTD. (UK)33 Stanley Road, London N15 3HB Email: scientificell@entodpharma.com

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Dr. Hadi Khazaei

Head of Department, Ocular Oncology, Oculoplasty & Orbit Service, Narayana Nethralaya (Benguluru, India)

DACRYOCYSTITIS:

• Tearing, crusting, fever.

• Digital pressure over the lacrimal sac may extrude

pus through the punctum.

• In chronic cases tearing may be the only symptom.

Causative organisms:

Most commonly caused by Staphylococcus aureus and

Streptococcus pneumoniae.*

Canaliculitis:

Signs and symptoms:

• Predominantly affects individuals over age 50

• Complaints center on a chronic, recalcitrant

unilateral red eye, and often epiphora.

• Discharge may range from a simple watery

consistency to full-blown mucopurulence.

• In many cases the patient will report previous

therapy with topical antibiotics.

• Recurrent episodes are common.

• Bio-microscopic inspection reveals a classic "pouting

punctum" in the involved eye--that is, the punctal

orifice is red, swollen and turned outward, like

pouting lips.

• Involved area is often tender to touch.

þ

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Pyrogen Free Production

Terminally Sterilised for Maximum Sterility

Automated Manufacturing with No Human Touch

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Op's ha ti hd an lI m g icni Es xa pc ew ro tih seS «»

September’ 13 September’ 13EDITION 3 EDITION 3

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Printed with Permission from: Dr. Hadi Khazaei,

To Contact Dr. Hadi Khazaei, Email: drhadikhz@gmail.com

Head of Department, Ocular Oncology, Oculoplasty & Orbit Service, Narayana Nethralaya (Benguluru, India)

* For Medical Professionals Use Only

Hyderabad, India.

4)Prevalence of bacterial pathogens causing ocular

infections in South India. Ramesh S, Ramakrishnan R,

Bharathi MJ, Amuthan M, Viswanathan S. Source Aravind Eye

Hospital & Postgraduate Institute of Ophthalmology,

Tirunelveli, Tamil Nadu- 627001, India.

5) Primary canaliculitis. Zaldívar RA, Bradley EA. Source

Department of Ophthalmology, Mayo Clinic and Mayo

Foundation, Rochester, Minnesota 55905, USA.

zaldivar.renzo@gmail.com

6)Bacteriology of chronic dacryocystitis in adult population

of northeast India. Das JK, Deka AC, Kuri GC, Bhattacharjee K,

Das D, Gogoi K. Source Sri Sankardeva Nethralaya, Beltola,

Guwahati, Assam, India. jk2269929@yahoo.co.in [corrected]

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• Digital manipulation of the punctum and/or

canaliculi may express discharge and/or concretions.

• Other important signs include erythema and swelling

of the lid and adnexal tissue, and a conjunctivitis

that is most pronounced inferiorly and nasally.

• Lacrimal probing reveals additional diagnostic signs.

• You will encounter a "soft stop" while probing the

canaliculus. This blockage indicates the presence of

concretions within the drainage system.

• Concurrent with this finding is the so-called "wrinkle

sign"; as your probe meets resistance, the overlying

skin of the medial canthus may compress and

wrinkle.

Causative organisms:

• Most often cause are bacterial pathogens

(Fusobacterium, Nocardia pathogens) though it can

also result from fungal or viral infections. In older

individuals, Actinomyces Israelii is the primary

etiology.

• Those under age 20 who present with canaliculitis

are more likely to manifest primary herpetic

infections.

• Other less common etiologies include Candida,

Fusarium and Aspergillus species.

Management:

Medical Treatment:

• In the presence of frank dacryocystitis: the cardinal

rule is to first treat the infection. The antibiotic of

choice is an anti-staphylococcal one, such as

aminoglycosides or fluoroquinolones group of drugs

e.g. cloxacillin (oral), moxifloxacin (topical).

Surgical Treatment:

• If the infection does not resolve and perforation is

impending: a dacryocystotomy should be performed.

• Relief of nasolacrimal duct obstruction by

dacryocystorhinostomy (DCR).

1. External or

2. Endonasal/ Endoscopic

Management of canaliculitis is twofold:

• Physical removal of associated foreign matter and

vigorous antimicrobial therapy. Small dacryoliths and

other debris may be expressed through the punctum

with direct manipulation using a cotton-tipped

applicator or lacrimal leavage using appropriate

solutions e.g. Moxifloxacin 0.5%.

• Larger or numerous stones often require surgical

canaliculotomy.

• Institute antimicrobial therapy only after alleviating

the blockage.

• Treatment options depend on the offending agent.

Obtain smears and cultures from the extruded

canalicular material.

• In cases of bacterial infection, irrigate (lacrimal

leavage) the canaliculus with moxifloxacin 0.5%

solution. Usually, you will then follow-up with topical

therapy (moxifloxacin ophthalmic solution) and

systemic antibiosis (penicillin or ampicillin) for 1-2

weeks.

• Treatment for herpetic infection consists of topical

trifluridine 1% five times daily for 2-3 weeks. Address

fungal infections by using nystatin 1:20,000

ophthalmic solution tid, as well as bi-weekly nystatin

irrigation.

• In case of actinomycosis and nocardia canaliculitis

amikacin ophthalmic solution can be effective after

frequent canalicular and sac leavage using

appropriate antimicrobial solutions.

• If treatment fails to eradicate the problem, or if

canalicular potency cannot be restored, a

dacryocystorhinostomy may be required.

Method:

Over 100 Patient with Post-Surgical Canaliculitis/

Dacryocystitis were enrolled in this parallel randomized

interventional study, which were further categorized into 2

groups, the treatment group (Group A) receiving 0.5 ml

lacrimal sac leavage with Moxifloxacin 0.5% ophthalmic

solution (4 Quin™ PFS prefilled syringe, Entod

Pharmaceuticals Ltd. [India]) 24hours after surgical

intervention for Chronic Dacryocystitis/ Canaliculitis, and the

control group (Group B) which received 0.5 ml of aqua

destilata (placebo) a day after their treatment. Clinical

observation of the symptoms in each group was performed

on the first until the sixth day after the inoculation using a

clinical grading scale. On the sixth day, the inoculated eyes

were examined for microbiological evaluations.

Results:

The total clinical grading scores of each group were similar

24hours after surgical intervention for Chronic

Dacryocystitis (P > 0.05). The total clinical grading scores of

Group A on the sixth day and the difference in total clinical

scores on the first and the sixth day were shown to be

significantly lower than that of Group B (P<0.05).

Microbiological analysis revealed that there was a lower

bacterial count in Group A (mean =1.16 ± 0.83 log CFU/ 0.1

mL) compared with Group B (mean = 3.04 ± 0.51logCFU/0.1

mL).

Conclusion:

Lacrimal Sac Leavage with Moxifloxacin 0.5% ophthalmic

solution(4 Quin™ PFS prefi l led syringe, Entod

Pharmaceuticals Ltd. [India]) 24 hours after surgical

intervention for Chronic Dacryocystitis appeared to be

effective and safe.

References:

1) Clinical bacteriology of dacryocystitis in adults.Coden DJ,

Hornblass A, Haas BD. Source Department of

Ophthalmology, University of California, San Diego

2) Clinical bacteriology of dacryocystitis in adults. Coden DJ,

Hornblass A, Haas BD. Source Department of

Ophthalmology, University of California, San Diego.

3) Primary canaliculitis: clinical features, microbiological

profile, and management outcome. Kaliki S, Ali MJ, Honavar

SG, Chandrasekhar G, Naik MN. Source Department of

Ophthalmic Plastic Surgery, LV Prasad Eye Institute,