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

Study Overview
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Brief Summary
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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.

Official Title
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A Multi Center, Open Label, Randomized, Two- Treatment, Single Dose, Crossover, Bioequivalence Study To Compare The Pharmacokinetics Of Marketed Product TobraDex® (Tobramycin And Dexamethasone Ophthalmic Ointment) To An Experimental Ophthalmic Sterile Ointment Containing Tobramycin 0.3% And Dexamethasone 0.1% W/W In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery

Conditions
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Bilateral Cataract

Intervention / Treatment
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* Drug: cataract surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tobramycin and dexamethasone ophthalmic test ointment<br>The test drug (tobramycin is an aminoglycoside antibiotic and dexamethasone is a corticosteroid) will be administered in one eye before the cataract surgery. | Drug: cataract surgery<br>* the patient will be dosed with the study drug into the V pocket is formed between the eye ball and the lower eyelid during cataract surgery.<br>|
| Active Comparator: TobraDex® ointment<br>The reference drug (tobramycin is an aminoglycoside antibiotic and dexamethasone is a corticosteroid) will be administered in another eye before the cataract surgery. | Drug: cataract surgery<br>* the patient will be dosed with the study drug into the V pocket is formed between the eye ball and the lower eyelid during cataract surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of dexamethasone in aqueous humor at different time points after administration of a single dose of each of the two drugs. | A series of aqueous humor samples will be collected from each eye of each patient. | 30 min - 8 hours |