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1 Clinical Trial Details (PDF Generation Date :- Sun, 02 Sep :54:31 GMT) CTRI Nuber CTRI/2010/091/ [Registered on: 08/11/2010] - Last Modified On 26/02/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No PMS Drug Single Ar Trial Post Marketing Surveillance Study for Systane in n Patients A Multi-Site Post Marketing Surveillance Study for Systane in n Patients Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (ulti-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) C Designation Affiliation Protocol Nuber Details of Principal Investigator Dr Ashit Shara Director O Eye Centre 4/c-2 Sector G, Jankipura, Sahara Straight Road 4/c-2 Sector G, Jankipura, Sahara Straight Road Lucknow UTTAR PRADESH Phone Fax Eail Designation docashit@gail.co Details Contact Person (Scientific Query) Jennifer Solo CRA Affiliation Alcon eployee Phone Fax Eail Designation Affiliation Unit No. 502, Tower-D, RMZ Infinity Beneganahalli, Old Madras road KARNATAKA jennifer.solo@alconlabs.co Details Contact Person (Public Query) Mangesh Chaudhary Clinical tea lead Phone Fax SRISTEK DLF Cyber City, Block 3, 8th Floor, Gachibowli,Hyderabad Hyderabad ANDHRA PRADESH page 1 / 6

2 Source of Monetary or Material Support Priary Sponsor Details of Secondary Sponsor Countries of Recruitent Sites of Study Eail Source of Monetary or Material Support > Alcon research will fund this post arketing surveilance study, this study has been copletely outsourced to Sristek, a CRO for purposes of data anageent and clinical operations. Type of Sponsor List of Countries of Principal Investigator Priary Sponsor Details Alcon Laboratories Pvt Ltd Unit No 502, 5th FloorTower-D, RMZ InfinityBeneganahalli, Old Madras Road Pharaceutical industry-global of Site Site Phone/Fax/Eail Dr. Nikhil s. Gokhale Gokhale Eye Hospital Anant Gokhale road, Near Portughese Church, Daadr (W), Mubai MAHARASHTRA Dr. Kuaraja G A G Eye Hospital Door No. 70, Officers Colony Puthur, Dr. Dilpreet Singh Angel Eyes C-35, Sarvodaya Nagar, Dr.Saar Basak Disha Eye Hospital 88,63A,Ghosh Para La ne,barrackpore, Kolkata WEST BENGAL Dr. Prasant Singhal Dr. Ashok Shara Dr Ravindra K Sachdeva Disha Eye Hospital (Hoogly) Pvt. Ltd Dr. Ashok Shara's Cornea Center Dr. Sachdev Eye Hospital 14, G.T. Road, Sheoraphuly, Hoogly, SCO , 2nd floor sector 22-A, Near Bus Stop, Opp. Parade Ground, Chandigarh CHANDIGARH 5h floor, Platinu Plaza, Near Pooja Abishek, Parel Point, Surat GUJARAT Dr. Ashok Gupta Drishti Eye Hospital S.C.O. sector 11, Panchkula,-Panchkula Panchkula nikgokhale@yahoo.co ageye@satya.net dilpreettuteja@yahoo.c o.in basak_sk@hotail.co p2singhal@sify.co asharapgius@yahoo. co drsachdev_19@sify.co page 2 / 6

3 Details of Ethics Coittee Dr. Biraj Jyoti Goswai Guwahati Eye Institute & Research Center HARYANA 1st Floor, G.S. road, Bhangagarh, Dr Narpat Solanki Mahavir Eye Hospital No 2, Sirur Park, Sesha dripura,, KARNATAKA Dr. Nitin Dedhia Ojas Laser Eye Surgery Center Roseland Building, 180 Waterfield Road, Bandra (W), Mubai MAHARASHTRA Dr. Ashit Shara O Eye Center 4/c-2 Sector G, Jankipura, Sahara Straight Road, Dr. Potti Sudhakar Sankara Eye Hospital Guntur- Vijayawada Expressway, Pedakakani, Guntur ANDHRA PRADESH Dr. Anant Vir Jain Sarvodaya Hospital & research Centre KJ-7, Kavi Nagar, Ghaziabad UTTAR PRADESH Dr. J.K.Bansal Suitra Clinic Tahseen Ganj, Hardori road, Lucknow UTTAR PRADESH DrBhaskar Roy Chaudhury Dr. Gopala Raju Taanash Eye Foundation Visakha nethra Jyothi Pvt. Ltd. 94 Babubagan, Dhakuria Kolkata WEST BENGAL Peddawaltair, Visakhapatna ANDHRA PRADESH geirc_07@rediffail.co pdns_2004@yahoo.co.i n ndedhia@vsnl.co docashit@gail.co guntur@sankaraeye.co aksarvodaya@yahoo. co suitraclinic@gial.co info@crihospitals.co.i n cvgraju@yahoo.co Dr.Sangeeta Wagh Wagh Eye Clinic 7/80, Lokanya Nagar,Opp.Union Bank, Navi Peth, sunsand@vsnl.co Pune MAHARASHTRA of Coittee Approval Status Date of Approval Is Independent Ethics Coittee? A G Eye Hospital Angel Eyes Clinico Disha Eye Hospital (Hoogly) Pvt. Ltd Disha Eye Hospital page 3 / 6

4 Regulatory Clearance Status fro DCGI Health Condition / Probles Studied Dr. Ashok Sharas Cornea Center Clinico Dr. Sachdev Eye Hospital Clinico Drishti Eye Hospital Clinico ethics Gokhale Eye Hospital Clinico ethics Guwahati Eye Institute & Research Center Mahavir Eye Hospital Ojas Laser Eye Surgery Center O Eye Center Clinico ethics Sankara Eye Hospital Sarvodaya Hospital & research Centre Suitra Clinic Clinico Taanash Eye Foundation Clinico Visakha nethra Jyothi Pvt. Ltd. Clinico Wagh Eye Clinic Status Date Approved/Obtained 07/10/2010 Health Type Patients Condition Patients with Moderate to severe Dry Eye Intervention / Type Details page 4 / 6

5 Coparator Agent Intervention Systane (Polyethylene glycol % & Propylene glycol 0.3%) Inclusion Criteria Exclusion Criteria Method of Generating Rando Sequence Method of Concealent Blinding/Masking Coparator Agent Age Fro Age To Gender Details Details Centralized Open Label Year(s) Year(s) Both Inclusion Criteria 1-2 drops in each eye, four ties daily (QID)for 2 weeks 18 years of age or older, of both sexes, and any race, Willing and able to ake all required visits and follow study instructions. A score of at least 2 (soe of the tie) on the subject-assessed Sypto Eligibility question. A sodiu fluorescein corneal staining su of? 3 in either eye. A best-corrected visual acuity of 0.6 logmar or better in each eye as assessed using an ETDRS chart. Exclusion Criteria A history or evidence of ocular or intraocular surgery in either eye within the past six onths. Lasik patients can be included if Lasik surgery was greater than 6 onths prior to the initiation of the study. A history of intolerance or hypersensitivity to any coponent of the study edications. A history or current evidence of the following: epithelial herpes siplex keratitis (dendritic keratitis); vaccine, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; ycobacterial infection of the eye; and/or fungal disease of the eye. Use any other topical ocular edication during the study period. Use of systeic edications that ay contribute to dry eye if the dosing regien has not been stable for at least 30 days prior to Visit 1. Additionally, the dosing regien ust reain stable throughout the study period. Medications known to contribute to dry eye include, but are not liited to, cold and allergy treatents, tricyclic antidepressants, and horone replaceent therapies.presence of ocular conditions such as active acute blepharitis, conjunctival infections, iritis, or any other ocular condition that ay preclude the safe adinistration of the test article. Unwilling to discontinue contact lens wear at least one week prior to Visit 1 and during the study period. Priary Outcoe Outcoe Tiepoints The su of the staining scores for the five corneal regions of each eye will be recorded at every visit. Tear break-up tie will be assessed. Changes fro baseline (Visit 1) in total staining scores and TBUT, will be coputed at each visit Baseline to Visit 2 (Week 2) Secondary Outcoe Outcoe Tiepoints Target Saple Size To assess the safety variables such as adverse events, best corrected visual acuity (logmar), and ocular signs (eyelids, iris/anterior segent/lens). These variables will be collected at all visits. Total Saple Size=300 Baseline to Visit 2 (Week 2) page 5 / 6

6 Powered by TCPDF ( PDF of Trial Phase of Trial Date of First Enrollent () Date of First Enrollent (Global) Estiated Duration of Trial Recruitent Status of Trial (Global) Recruitent Status of Trial () Publication Details Brief Suary Saple Size fro =300 Post Marketing Surveillance 07/01/2011 No Date Specified Years=0 Months=3 Days=0 Copleted Title A Multi-Site Post Marketing Surveillance Study for Systane in n Patients to Evaluate the Physical Effects of Systane with Moderate to Severe Dry Eye. Procedure It is a two-week, prospective study. At Visit 1, subjects who qualify for study participation will undergo an undilated ophthalic exaination of both eyes along with corneal staining and the study drug will be dispensened. Thereafter, subjects will be seen for evaluations of the study edications at Visits 2 (Day 14). Subjects to be enrolled The total nuber of patients estiated to be enrolled is 300. Twenty sites will be taking part in the study, with 15 patients to be enrolled at each site. The anticipated enrollent date is on 25th Oct page 6 / 6