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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

NCT02734459 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 756

Last updated 2016-04-12

No results posted yet for this study

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.

Conditions

  • Bilateral Cataract

Interventions

DRUG

cataract surgery

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.

Sponsors & Collaborators

  • Genzum Life Sciences

    collaborator INDUSTRY

  • Semler Research Center Pvt. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-10-31
Completion
2016-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02734459 on ClinicalTrials.gov