A Bioequivalence Study to Compare the Pharmacokinetics (PK) Of Marketed Product TobraDex® To An Experimental Ophthalmic Sterile Ointment Containing Tobramycin And Dexamethasone In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery
A Bioequivalence Study to Compare the Pharmacokinetics (PK) Of Marketed Product TobraDex® To An Experimental Ophthalmic Sterile Ointment Containing Tobramycin And Dexamethasone In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery
Each patient will be randomized to receive one dose of the test article in one eye and one
 dose of the reference formulations in the contralateral eye. One eye will be selected as the
 initial eye for cataract surgery and aqueous humor collection and hence will be dosed and
 operated on first. Followed by the second eye which will be dosed no early than a week
 followed by aqueous humor collection as per specified time points and no later than 35 days
 following the first eye again prior to the cataract surgery.
Inclusion Criteria:

 -  Be male or female 18 years of age and above

 -  Presence of visually significant cataracts in both eyes

 -  Have a chief complaint consistent with visually significant cataracts

 -  Be able to communicate effectively with the study personnel and be able to understand
 and follow directions

 -  Be medically fit with clinically acceptable laboratory profiles and ECG

 -  Be willing to carry out the required pre op directions and post op care and be able to
 make the scheduled appointment

 -  Have given the written informed consent for participation in the study

 -  In addition, female patients of child bearing potential age must have a negative urine
 pregnancy test

 Exclusion Criteria:

 -  Participation in any ophthalmic indicative bioavailability/ bioequivalence/
 Pharmacokinetic study or received an ophthalmic indicative investigational drug within
 a period of three months prior to screening

 -  Presence or history of recent viral corneal disorder or active corneal condition which
 is contraindicated.

 -  Presence or history of uveitis or uveitis

 -  Presence of retinal disorders

 -  Ocular trauma within three months of the trial

 -  Patients who had received topical and or systemic/ oral steroids

 -  Uncontrolled diabetes

 -  History of any allergies

 -  Known hypersensitivity or allergy to TobraDex® in combination or its components

 -  Clinical laboratory test values outside the acceptable reference range and when
 confirmed on re-examination deemed to be clinically significant as determined by the
 investigator(s)

 -  Clinically significant illness during 3 weeks prior to Visit 1 (as determined by the
 investigators)

 -  Presence of a clinically significant systemic disorder