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Completed

NCT Number: 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

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.

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Key information

Conditions

Bilateral Cataract Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cataract surgery

Drug

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.

Primary outcomes

  1. Concentration of dexamethasone in aqueous humor at different time points after administration of a single dose of each of the two drugs.

    Time frame: 30 min - 8 hours

    A series of aqueous humor samples will be collected from each eye of each patient.

Other outcomes

  1. Time at which maximum mean drug concentration (Tmax) is achieved, in aqueous humor after the administration of test and reference drugs.

    Time frame: 30 min - 8 hours

  2. AUC under the concentration-time curve from time-zero to the time t for test and reference drugs

    Time frame: 30 min - 8 hours

  3. Maximum drug concentration (Cmax) achieved, in aqueous humor after the administration of test and reference drugs.

    Time frame: 30 min - 8 hours

Sponsors and collaborators

Lead sponsor

Semler Research Center Pvt. Ltd.

Industry

Collaborators

  • Genzum Life Sciences

Registry information

Official study 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

Acronym: TBO

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Apr 12, 2016
Registry last updated
Apr 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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