Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to demonstrate the bioequivalence of the combination test agent, prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to PredForte (prednisolone acetate 1.0%) ophthalmic suspension. Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisolone and Tobramycin | Experimental | Prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension. One drop of test agent will be instilled in the inferior cul de sac of the operative eye prior to cataract extraction. |
|
| Prednisolone | Active Comparator | Prednisolone acetate 1.0% ophthalmic suspension. One drop of test agent will be instilled in the inferior cul de sac of the operative eye prior to cataract extraction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone and Tobramycin | Drug |
| ||
| Prednisolone |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate at various time points | Comparison of aqueous humor concentrations of prednisolone acetate at various time points | 2 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tim McNamara, PharmD | ISTA Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Donald E. Beahm, MD | Great Bend | Kansas | 67530 | United States | ||
| Cornea Consultants/Laser Eye Consultants of Boston |
Not provided
| ID | Term |
|---|---|
| D015817 | Eye Infections |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005128 | Eye Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D014031 | Tobramycin |
| C009935 | prednisolone acetate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Great Lakes Eye Care | Saint Joseph | Michigan | 49085 | United States |
| Eyesight Ophthalmic Services, PA | Portsmouth | New Hampshire | 03801 | United States |
| Texan Eye Care PA | Austin | Texas | 78705 | United States |
| Houston Eye Associates | Houston | Texas | 77025 | United States |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |