A Bioequivalence Study of Tobradex AF
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ClinicalTrials.gov Identifier: NCT00362895 |
Recruitment Status :
Completed
First Posted : August 15, 2006
Last Update Posted : March 5, 2012
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Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Actual Enrollment : | 995 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (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 |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | August 2006 |
Actual Study Completion Date : | August 2006 |
Arm | Intervention/treatment |
---|---|
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® |
- Concentration of dexamethasone in aqueous humor following a single topical ocular administration

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 or older
- Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
- Under 18
- Other protocol-defined exclusion criteria may apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00362895
United States, Texas | |
Contact Alcon for Trial Location(s) | |
Fort Worth, Texas, United States, 76134 |
Responsible Party: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT00362895 |
Other Study ID Numbers: |
C-05-23 |
First Posted: | August 15, 2006 Key Record Dates |
Last Update Posted: | March 5, 2012 |
Last Verified: | March 2012 |
Cataract Lens Diseases Eye Diseases Tobramycin Tobramycin, Dexamethasone Drug Combination Dexamethasone Dexamethasone acetate BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
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