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Study of Ocular Hypotensive Effect and Tolerability of Fixed Combination Brinzolamide 1% and Brimonidine 0.2% in Indian Eyes with Open Angle Glaucoma

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STUDY OF OCULAR HYPOTENSIVE EFFECT AND TOLERABILITY OF FIXED COMBINATION BRINZOLAMIDE 1% AND BRIMONIDINE 0.2% IN INDIAN EYES WITH OPEN ANGLE GLAUCOMA DISSERTATION SUBMITTED TOWARDS FULFILMENT OF THE RULES AND REGULATIONS FOR THE M.S. BRANCH III OPHTHALMOLOGY EXAMINATION OF THE TAMILNADU DR. M.G.R. MEDICAL UNIVERSITY TO BE HELD IN APRIL, 2018 1 STUDY OF OCULAR HYPOTENSIVE EFFECT AND TOLERABILITY OF FIXED COMBINATION BRINZOLAMIDE 1% AND BRIMONIDINE 0.2% IN INDIAN EYES WITH OPEN ANGLE GLAUCOMA Christian Medical College , Vellore Dr. Sujitha Ramesh 2 BONAFIDE CERTIFICATE This is to certify that this dissertation entitled “Study of ocular hypotensive effect and tolerability of fixed-combination Brinzolamide 1% and brimonidine 0.2% in Indian eyes with open angle glaucoma ” done towards fulfillment of the requirements of the Tamil Nadu Dr MGR Medical University, Chennai for MS Branch III (Ophthalmology) examination to be conducted in April 2018, is the bonafide original work of Dr. Sujitha Ramesh, Post Graduate student in the Department of Ophthalmology, Christian Medical College, Vellore Dr. Andrew David Braganza, MS The Principal, Professor and Head of the Department, Christian Medical College, Department of Ophthalmology, Vellore- 632001 Christian Medical College, Vellore- 632001 3 BONAFIDE CERTIFICATE This is to certify that this dissertation entitled “Study of ocular hypotensive effect and tolerability of fixed-combination Brinzolamide 1% and brimonidine 0.2% in Indian eyes with open angle glaucoma ” done towards fulfillment of the requirements of the Tamil Nadu Dr MGR Medical University, Chennai for MS Branch III Ophthalmology examination to be conducted in April 2018, is the bonafide original work of Dr. Sujitha Ramesh, Post Graduate student in Ophthalmology, Christian Medical College, Vellore Guide Dr. Arathi Simha R Associate Professor, Department of Ophthalmology, Christian Medical College, Vellore- 632001. Co guides: Dr. Andrew Braganza ( Professor) Dr. Lekha Mary Abraham (Professor) 4 BONAFIDE CERTIFICATE This is to certify that this dissertation entitled “Study of ocular hypotensive effect and tolerability of fixed-combination Brinzolamide 1% and brimonidine 0.2% in Indian eyes with open angle glaucoma ” done towards fulfillment of the requirements of the Tamil Nadu Dr MGR Medical University, Chennai for MS Branch III Ophthalmology examination to be conducted in April 2018, is the bonafide original work of Dr. Sujitha Ramesh, Post Graduate student in Ophthalmology, Christian Medical College, Vellore Dr. Sujitha Ramesh Post Graduate student, Department of Ophthalmology, Christian Medical College, Vellore - 632001 5 ACKNOWLEDGEMENT At the outset, I want to thank God for bringing me this far and guiding me in every step of my career. I would like to express my sincere gratitude to my guide, Dr. Arathi Simha R, for her patience, guidance, suggestions, healthy criticism in the conduct of this work, from its inception to the conclusion. Her advice has been invaluable in the final presentation of the thesis in its current form. Her insight into this work and immense knowledge has been invaluable and a great learning experience. Also, her inputs for the statistical analysis were very useful. This is my first insight into research and I feel privileged to have her as my mentor. I would also like to express my heartfelt gratitude to my co guides Dr. Andrew Braganza and Dr. Lekha Mary Abraham. Their time, patience, suggestions, encouraging and reassuring words, moral support have been pivotal in the completion of this work. There’s a kind of inspiration that’s not much more than doing the right thing in the right way, and I feel extremely lucky to have Sir and madam as my co guide. Their help was indispensible for this study. I would also like to thank my biostatistician, Mrs. Mahasampath Gowri for helping me with the statistical analysis inspite of her busy schedule. I am extremely indebted to all my colleagues for being understanding and extending their support in helping me to complete this work. A special thanks to Sharmili , Nidhi Priyanka , Bhavagna , Roshini , Joseph , Bharath , Shiju and Swetha . My heartfelt thanks to all those who have contributed in ways, small and big, to complete this endeavor 6 ANTI PLAGARIASM CERTIFICATE: 7 TABLE OF CONTENTS Content Page number Introduction 1 Aims and Objectives 3 Literature Review 5 Materials and Methods 44 Results 51 Discussion 67 Limitations 73 Conclusion 74 References 76 Annexure IRB approval letter 95 Patient information sheet 100 Consent form 103 Clinical research proforma 111 Colour plate 115 Excel sheet 116 8 INTRODUCTION Glaucoma represents a progressive optic neuropathy characterized by nerve fiber layer defects which lead to characteristic optic disc changes and visual field defects (1). It has a multifactorial aetiology with intraocular pressure (IOP) being the only major modifiable risk factor (2).The mainstay of treatment involves lowering of the intraocular pressure by various methods. Although there is no absolutely ‘safe’ pressure that guarantees prevention of progression, lowering intraocular pressure to the low-normal range usually arrests or slows the progression of glaucoma. The two main modalities of treatment include surgical and medical. Usually 25% - 30% reduction in baseline intraocular pressure (3)(4)(5) or achievement of Target intraocular pressure is the goal of treatment. Target intraocular pressure is defined as the upper limit of the range of measured intraocular pressures adequate to stop progressive pressure induced damage of optic nerve head. Medical management consists of topical administration of various classes of anti-glaucoma medications in the form of eye drops. The anti-glaucoma medications available include β blockers (Timolol 0.5%, Betaxolol 0.5%), alpha adrenergic agonists (brimonidine 0.2%), Prostaglandin analogs (latanoprost 0.005%, Travaprost 0.004%, Bimataprost 0.03%), Carbonic anhydrase inhibitors (dorzolamide 2% ,brinzolamide 1%) and Parasypathomimetics (Pilocarpine 1-4%). Monotherapy is often insufficient to achieve the optimal reduction of Intraocular pressure . Combination of drugs is hence often required. In order to achieve ease of administration and reduction of side effects of preservatives of multiple drops, fixed combinations are used. Also compliance is better with fixed therapy than individual mutiple medications(6). Till recently, Timolol, a beta blocker was the only additional drug available in fixed combination along with various other antiglaucoma medications like Prostaglandin analogues, Carbonic 1 anhydrase inhibitors and Alpha adrenergic agonists (7). However beta blockers cannot be used in asthmatics and patients with heart blocks. Also, in patients with uveitis as well as those planned for intraocular surgeries, prostaglandin analogues are best avoided due to the risk of increased incidence of cystoid macular oedema or worsening of uveitis (8). Carbonic anhydrase inhibitor and Alpha adrenergic agonist are the drugs preferred in these patients. Recently fixed combination Carbonic anhydrase inhibitor and Alpha adrenergic agonist is available in the market. It can be used as first line therapy (9)(10) or added on in patients wherein intraocular pressure control is inadequate with monotherapy with Prostaglandin analogs and Beta blockers are contraindicated(11)(12). The efficacy of fixed combination of carbonic anhydrase inhibitor and alpha adrenergic agonist has been studied in various Caucasian studies (6)(13)(14) and has been shown to achieve a 32% to 34 % (15) (16) reduction of intraocular pressure. They have also been used as an additional therapy along with Prostaglangin analogs and has been found to achieve additional 25 % reduction in Intraocular pressure (11). The fixed dose combination has now recently become available in the Indian market as the preparation – Simbrinza TM (Fixed combination of brinzolamide 1% and brimonidine 0.2% ,Alcon laboratories). However there are no studies in Indian eyes. Hence we looked at the ocular hypotensive effect and tolerability of fixed dose combination of Carbonic anhydrase inhibitor and Alpha adrenergic agonist in our patients. 2 AIM: This study aims to assess the ocular hypotensive effect and tolerability of fixed combination of brinzolamide 1% and brimonidine 0.2% in Indian patients with Open angle glaucoma. 3 PRIMARY OBJECTIVES: 1. To determine the reduction in Intraocular pressure achieved in patients with open angle glaucoma by the fixed combination brinzolamide1% and brimonidine 0.2% at 1 month as measured during office hours. 2. To determine the tolerability and side effect profile of fixed combination brinzolamide 1% and brimonidine 0.2% . Secondary objective: To determine the 24 hour profile of intraocular pressure in patients on fixed combination of brinzolamide1% and brimonidine 0.2% 4 LITERATURE REVIEW: Glaucoma comprises a multifactorial group of diseases characterised by chronic progressive anterior optic neuropathy that is accompanied by a characteristic cupping and atrophy of the optic disc, and visual field loss, with elevated intra-ocular pressure being the only modifiable risk factor. (17) About 12 million people in India are affected by glaucoma accounting for 12.8% of the blindness in the country. Early population based studies reported a prevalence of glaucoma between 2% and 13% (21). The Vellore Eye Survey (VES) reported a prevalence of Primary open angle glaucoma (POAG) as 0.41%, ocular hypertension (OHT) 3.08 %(22). The Andhra Pradesh Eye Disease
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