A Bioequivalence Study of Tobradex AF

• ClinicalTrials.gov Identifier: NCT00362895
• Recruitment Status: Completed
• First Posted: August 15, 2006
• Last Update Posted: March 5, 2012
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Tracking Information

• First Submitted Date: August 9, 2006
• First Posted Date: August 15, 2006
• Last Update Posted Date: March 5, 2012
• Study Start Date: April 2006
• Actual Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 2, 2012): Concentration of dexamethasone in aqueous humor following a single topical ocular administration
• Original Primary Outcome Measures (submitted: August 9, 2006): concentration of dexamethasone in aqueous humor following a single topical ocular administration
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (submitted: August 9, 2006): changes in external and internal ocular structures, IOP, vision and other side effects
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Bioequivalence Study of Tobradex AF
• Official Title: A Double-Masked, Parallel-Group, Randomized, Single-Dose Bioequivalence Study of Tobradex AF Suspension and TOBRADEX Ophthalmic Suspension
• Brief Summary: The purpose of the study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Cataract

Intervention

• Drug: Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension
  One drop in the study eye, single dose
• Drug: Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)
  One drop in the study eye, single dose
  Other Name: TOBRADEX®

Study Arms

• Experimental: Tobradex AF
  Intervention: Drug: Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension
• Active Comparator: TOBRADEX
  Intervention: Drug: Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 2, 2012): 995
• Original Enrollment (submitted: August 9, 2006): 1000
• Actual Study Completion Date: August 2006
• Actual Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 18 or older
• Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• Under 18
• Other protocol-defined exclusion criteria may apply

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00362895
• Other Study ID Numbers: C-05-23
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Alcon Research
• Study Sponsor: Alcon Research
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Alcon Research
• Verification Date: March 2012