Clinical trial NCT02734459: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bilateral Cataract
Lead sponsor: Semler Research Center Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Genzum Life Sciences
First posted: 2016-04-12
Enrollment: 756
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Concentration of dexamethasone in aqueous humor at different time points after administration of a single dose of each of the two drugs.
timeFrame: 30 min - 8 hours
Secondary outcomes:
Other outcomes:
measure: Time at which maximum mean drug concentration (Tmax) is achieved, in aqueous humor after the administration of test and reference drugs.
timeFrame: 30 min - 8 hours
measure: AUC under the concentration-time curve from time-zero to the time t for test and reference drugs
timeFrame: 30 min - 8 hours
measure: Maximum drug concentration (Cmax) achieved, in aqueous humor after the administration of test and reference drugs.
timeFrame: 30 min - 8 hours
Locations:
Study officials:
References: