A Bioequivalence Study of Tobradex AF
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00362895
First received: August 9, 2006
Last updated: March 2, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cataract |
Drug: Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension Drug: Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double-Masked, Parallel-Group, Randomized, Single-Dose Bioequivalence Study of Tobradex AF Suspension and TOBRADEX Ophthalmic Suspension |
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Concentration of dexamethasone in aqueous humor following a single topical ocular administration
| Enrollment: | 995 |
| Study Start Date: | April 2006 |
| Study Completion Date: | August 2006 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Tobradex AF |
Drug: Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension
One drop in the study eye, single dose
|
| Active Comparator: TOBRADEX |
Drug: Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)
One drop in the study eye, single dose
Other Name: TOBRADEX®
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 or older
- Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
- Under 18
- Other protocol-defined exclusion criteria may apply
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00362895
Please refer to this study by its ClinicalTrials.gov identifier: NCT00362895
Locations
| United States, Texas | |
| Contact Alcon for Trial Location(s) | |
| Fort Worth, Texas, United States, 76134 | |
Sponsors and Collaborators
Alcon Research
More Information
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT00362895 History of Changes |
| Other Study ID Numbers: |
C-05-23 |
| Study First Received: | August 9, 2006 |
| Last Updated: | March 2, 2012 |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Tobramycin Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 25, 2017