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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. Name of the Candidate: Dr. ANUSHA.S.J

and Address ROOM NO - 420

KIMS GIRLS HOSTEL

BANASHANKARI 2nd STAGE

BANGALORE – 560 070

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2. Name of the Institution: KEMPEGOWDA INSTITUTE OF

MEDICAL SCIENCES

BANGALORE – 560 070

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3. Course of the Study and Subject: M.D. IN PHARMACOLOGY

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4. Date of Admission to Course: 8th JULY 2013

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5. Title of the Topic: A COMPARATIVE STUDY OF EFFICACY AND TOLERABILITY OF OLOPATADINE, KETOTIFEN AND EPINASTINE IN SEASONAL ALLERGIC CONJUNCTIVITIS

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6. Brief Resume of the Intended Work

6.1 Need for Study

Allergic conjunctivitis collectively refers to allergic inflammation involving lid, conjunctiva and/or cornea. Seasonal allergic conjunctivitis (SAC) is the most common allergic disease affecting the eye, with an estimated prevalence of 15% to 20%. Although sequelae affecting patients’ vision are rare, the symptoms are distressing and may have significant socioeconomic impact, affecting the quality of life, daily activities, productivity, school performance etc.

The treatment options for allergic conjunctivitis include cold compression, artificial tears, topical antihistaminics, NSAID, mast cell stabilizers, and steroids. The latest generation multiple action topical antiallergic agents like olopatadine, ketotifen and epinastine, possesses antihistaminic, mast cell stabilizing, and anti-inflammatory actions without the classical topical or systemic steroidal side effects, and are now been recommended as first line agents in the treatment of SAC. As there are few studies and reports regarding the comparative efficacy and tolerability of the topical antihistaminics in SAC in Indian population, the present study will be taken up.

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6.2 Review of literature

Allergic conjunctivitis is one of the most common nontraumatic extra-ocular inflammatory condition, and includes seasonal allergic conjunctivitis (SAC), perennial allergic conjunctivitis (PAC), atopic keratoconjuntivits (AKC) and drug induced allergic conjunctivitis (DIAC).1, 2

SAC, also known as vernal conjunctivitis or spring catarrh, is the most common form of allergic conjunctivitis, and occurs on a seasonal basis often as part of seasonal rhino- conjunctivitis (hay fever), and is most frequently caused by grass, tree and weed pollens and outdoor moulds which peak at different times of the year.1, 3 It is characterized by recurrent bilateral conjunctivitis which usually presents with itching, redness, lacrimation, burning, stinging, photophobia, watery/mucoid discharge.1, 4 These episodes are often accompanied by clinical signs of lid edema, conjunctival chemosis, hyperemia, and papillary reactions that can be appreciated on examination.4

Management of SAC is aimed at preventing and alleviating symptoms.3 Treatment options for SAC include topical steroids, NSAIDs, antihistaminics and mast cell stabilizers.2 Although considered very effective, the use of topical corticosteroids is limited by well known side effects like cataract, glaucoma and increased susceptibility to infection, and hence not the preferred option except for severe refractory forms of allergic conjunctivitis.2, 4 Topical NSAIDs are known to produce adverse effects like corneal stinging, burning, conjunctival hyperemia, punctuate keratopathy and persistent epithelial erosion.5 H1 blockers generally have limited efficacy in SAC.6 However, certain new generation H1 blockers with additional actions like mast cell stabilization, PAF antagonism, inhibition of eosinophil accumulation, and hence referred as multiple action topical antiallergic agents which include olopatadine, ketotifen , epinastine, azelastine etc, are now considered as first line agents in the treatment of SAC.7

Olopatadine is a long acting multiple action topical antiallergic agent with H1 blocking, mast cell stabilizing and also reducing ICAM-1 expression.4 It is effective by once daily instillation and can be used in both adults and children above three years. It has a good tolerability apart from occasional occurance of headache and stinging/burning of the eye.7

Ketotifen is a benzocycloheptathiophene with a noncompetitive H1 blocking, mast cell stabilizing and PAF antagonistic action and also inhibiting eosinophil chemotaxis. It is generally used by twice daily instillation and currently approved for SAC.4, 8 Irritation, pain, and punctate keratitis are commonly reported after topical application.7

Epinastine is a nonsedating H1 receptor blocker with mast cell stabilizing and anti-inflammatory properties. It is effective by twice daily instillation and can be used in adult and children above 3 years. Burning sensation, folliculosis, pruritis, hyperemia have been reported on topical use.9

Other topical multiple action antiallergic agents with proven efficacy for SAC include azelastine, emedastine, alcaftadine. 9

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6.3 Objectives of the Study

a. To compare the efficacy of olopatadine (0.2%), ketotifen (0.025%) and epinastine (0.05%) in SAC.

b. To compare the tolerability and acceptability of above medications in SAC.

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7. Materials and Methods

7.1 Source of Data

Patients with SAC attending the ophthalmology OPD, KIMSH & RC, KR road VV Puram, Bangalore-4

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7.2 Method of Collection of Data (including sampling procedure, if any)

A. Methodology and Type of Data Collection

Following IEC approval and clearance, the subjects fulfilling the inclusion/exclusion criteria will be randomly assigned into three groups of 30 in each for receiving olopatadine, ketotifen or epinastine. Written informed consent will be obtained from all the subjects after fully explaining the study procedure. For subjects under 18 yrs informed consent will be taken from parents/legal representatives.

All the subjects will be examined for visual acuity and any other intra ocular pathology by slit lamp examination. The study medications will be instilled into the affected eyes (one/both) twice daily for 4 weeks. Patients’ attendants will be properly instructed regarding the instillation and proper preservation of the medications. Clinical signs and symptoms will be assessed at baseline and at weekly intervals for 4 weeks. The clinical parameters of SAC such as ocular itching, hyperemia/congestion and regression of papillary lesions will be assessed by grading on a 4-point scale (none to severe).

The tolerability will be assessed by observing and monitoring for any adverse reactions/events during the study period.

The study subjects will be instructed to report/consult in the event of any adverse effects/reactions during the study period. Non responders and the subjects developing severe adverse reactions will be withdrawn from the study and rescue medications will be administered.

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B. Inclusion Criteria

a. Patients of all age groups above 3 years from either gender diagnosed as SAC with itching of variable severity and seasonal exacerbations;

b. Patients with more than 2-3 episodes in the past 2 yrs

c. Patients with both palpebral and bulbar manifestations.

d. Willingness to give informed consent and availability for regular follow-up

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C. Exclusion Criteria

a. Patients with acute systemic allergic manifestations like severe bronchial asthma and coexisting allergic rhinitis on systemic therapy.

b. Presence of any other form of allergic conjunctivitis - gaint papillary conjunctivitis, and atopic conjunctivitis

c. Presence of active bacterial/viral conjunctivitis

d. History of ocular herpes

e. History of severe dry eye

f. Lesions involving cornea

g. SAC associated with ocular surface disease

h. Subjects who had used topical steroids/NSAIDs in the past 2 weeks

i. Patients who had participated in any clinical trial for SAC in the past 2 weeks

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D. Sample Size

Selective sample of 90 subjects randomly assigned into 3 groups of 30 each for receiving olopatadine, ketotifen or epinastine.

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E. Sample Design

Random sampling procedure

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F. Study Design

Randomized, comparative, open label, parallel group study

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G. Study Period

January 2014 – June 2015 (1 ½ years)

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H. Place of Study

Department of Ophthalmology, KIMS Hospital and Research Centre, Bangalore

I. Statistical Methods Involved

The data obtained will be summarized using descriptive statistics. Kruskal Wallis test will be used for testing the significance of differences in the study parameters of all the three groups and Mann-Whitney for between the group comparison. The results are considered significant whenever p ................
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