KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES(Affiliated to Bangalore University, Rajiv Gandhi University of Health Sciences

& recognised by Medical Council of India, New Delhi)BANASHANKARI 2ND STAGE, BANGALORE - 560 070PH. COLLEGE OFFICE: 080-26712791, 26712792, FAX: 080-26712798HOSPITAL OFFICE: 080-26679560, 26679202 FAX: 080-26613225

website: www.kimscollege.org Email:.bngkims@kar.nic.in

From,The member secretary,Institutional Ethics Committee,Kempegowda Institute of Medical Sciences,Bangalore.

To,Dr. H. N. Sowbhagya,Professor,Department Ophthalmology,KIMS, Bangalore.

Date: 17/01/11

Study title: A Multi Center, Open Label, Randomized, Two-Treatment, Two-Sequence, SinglePeriod, Parallel, Single Dose, Bioequivalence Study To Compare The Pharmacokinetics OfMarketed Product TobraDex® (Tobramycin And Dexamethasone Ophthalmic Suspension) ToAn Experimental Ophthalmic Sterile Suspension Containing Tobramycin 0.3% AndDexamethasone 0.1 % WN In Aqueous Humor In Patients Undergoing Indicated CataractSurgery. Protocol No: S-10-039

Dear Dr. H. N. Sowbhagya,

With reference to the above mentioned study, the following documents were received from youand the same has been reviewed by us

S.No DocumentsVersion No: And Date

1.

Clinical Study Protocol Version Number 3.0 Dated 07 Dec 2010

2.

Informed Consent Form In English Version Number 3.0 Dated:30-Nov-2010

3.

Informed Consent Form In Kannada Version Number 3.0 Dated:30-Nov-2010

4.

Back Translation Form Kannada to EnglishVersion Number 3.0 Dated:30-Nov-2010

5.

Informed Consent Form In Hindi Version Number 3.0 Dated:30-Nov-2010

6.

Back Translation Form Hindi to English Version Number 3.0 Dated:30-Nov-2010

7.

Informed Consent Form In Tamil Version Number 3.0 Dated:30-Nov-2010

8.

Back Translation Form Tamil to English Version Number 3.0 Dated:30-Nov-2010

9.

Informed Consent Form In Malayalam Version Number 3.0 Dated:30-Nov-2010

10. Back Translation Form Malayalam to EnglishVersion Number 3.0 Dated:30-Nov-2010

11.

Informed Consent Form In Urdu Version Number 3.0 Dated:30-Nov-2010

12.

Back Translation Form Urdu to English Version Number 3.0 Dated:30-Nov-2010

13.

CRF Version Number 2.0 Dated:22-Dec-2010

14.

Clinical Study Protocol Administrative Number 2

Change 15.Certificate of Insurance NA

16.

DCGI Submission Letter Dated: 08-Dec-2010

17.

Product Monograph. NA

15.

Curriculum Vitae of the Principal NA

Investigator. 16.Undertaking by the Investigator. NA

17.

Source Note template NA

18.

Site Specific SOP NA

The following members of the Ethics Committee were present during the meeting held at ..KIMSCONFERENCE HALL. on 30/12/2010. at ... 11.00 AM and have decided to approve the abovementioned documents for use in referenced study.

S.No Name of Member QualificationDesignationIProf. Himalakshi Chair person

2Dr.K.Ananda Prof and HOD,ForensicMember secretary

medicine3Dr.M.K.Sudarshan ProfofcommunityDeanKIMS

medicine Member4Dr.AnjanapP'a Prof of surgeryMedical superintendent

Member5Dr.Keshava murthy S ProfandMember

HOD,Paediatrics6Dr.H.Pundareekaksha ProfandHODofMember

pharmacology7Dr. Lalitha Associate.profofMember

anatomy8

Smt. Poornamma Prof of sociologyMember9

Kalavathi Social workerMember

We confirm that neither you nor your study team members participated in the deliberations of theEthics Committee & did not vote on the proposal for this study.

Thanking you,

A. '. .0"

.• mber Secretary \h' Comrth 0·tutional ~t Icsf Mettle I $t\once

owda Institute 0 010Bal'\galore•560