(Pivotal study)PK of TobraDex is compared with Tobramycin 0.3% And Dexamethasone 0.1%(Study drug) W/V In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/003008

Enrollment

552

Registered

2010-12-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Bilateral Cataract

Interventions

Intervention1: Tobramycin (0.3%)+Dexamethasone (0.1%): single dose Control Intervention1: tobradex: single dose

Eligibility

Inclusion criteria

Inclusion criteria: a. Be male or female 18 to 55 years of age b. Presence of cataract in both the eyes and indicated for extracapsular cataract extraction e. Be able to communicate effectively with the study personnel h. Be medically fit with clinically acceptable laboratory profiles, ECG j. Be declared eligible to participate in the study by the investigator

Exclusion criteria

Exclusion criteria: a. Participation in any bioavailability/bioequivalence/Pharmacokinetic study or received an investigational drug within a period of 3 months prior to check in b. Presence or history of epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella of the cornea and conjunctiva c. History of ?recent (last 15 days)? or ?active? viral diseases of the cornea and conjunctiva e. Ocular trauma within 3 months of the trial, active external ocular disease, inflammation, or infection (mycobacterial or fungal disease) of the study eye and corneal diseases or disruption m. Patients who have: i. Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the physician /investigator (s). ii. Pulse rate below 60 per minute or above 100 per minute. iii. Respiratory rate below 15 or above 20 breaths per minute. iv. Oral temperature less than 96.2oF or more than 99.8oF

Design outcomes

Primary

Measure	Time frame
to evaluate the pharmacokinetics (PK) of the steroid component (dexamethasone) of the combination drug invivo in aqueous humorTimepoint: as per randomization list	—

Secondary

Measure	Time frame
to monitor the safety and tolerability of a single dose of marketed TobraDex® and a single dose of investigational ophthalmic sterile suspension containing tobramycin 0.3% and dexamethasone 0.1% w/v when administered in patients undergoing indicated cataract surgeryTimepoint: as per randomization list	—

Countries

India

Contacts

Public ContactDr Santosh Kadam

Semler Research Center

drjiyochacko@semlerresearch.com080-42627200

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026