A Bioequivalence Study of Tobradex AF
Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00362895
Collaborator
(none)
995
1
2
4
248.2
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
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
:
Apr 1, 2006
Actual Primary Completion Date
:
Aug 1, 2006
Actual Study Completion Date
:
Aug 1, 2006
Arms and Interventions
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 Names:
|
Outcome Measures
Primary Outcome Measures
- Concentration of dexamethasone in aqueous humor following a single topical ocular administration []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Contact Alcon for Trial Location(s) | Fort Worth | Texas | United States | 76134 |
Sponsors and Collaborators
- Alcon Research
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00362895
Other Study ID Numbers:
- C-05-23
First Posted:
Aug 15, 2006
Last Update Posted:
Mar 5, 2012
Last Verified:
Mar 1, 2012
Additional relevant MeSH terms: