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The objective of this study is to identify any adverse events or adverse drug reactions through post-marketing surveillance under routine clinical practice
The objective of this study is to identify any adverse events or adverse drug reactions through post-marketing surveillance under routine clinical practice after marketing authorization of Lotemax ophthalmic suspension 0.5%
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loteprednol Etabonate | Experimental | Ophthalmic Gel 0.5% |
|
| Prednisolone Acetate 1% Oph Susp | Experimental | Ophthalmic suspension 0.5% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loteprednol Etabonate | Drug | Ocular administration of study drug. at least once within any indication of the label. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | All adverse events that occurred from the first dose of the study drug regardless of causality to the study drug. Changes in all undesirable medical findings and all adverse events occurring with the use of the study drug. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Seasonal Allergic Conjunctivitis | Signs and symptoms of seasonal allergic conjunctivitis: The efficacy assessment will be evaluated according to the classification: improved, unchanged, worsened, impossible to assess. | 4 years |
| Giant Papillary Conjunctivitis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Binu Alexander, MD | Valeant Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Korea Ltd | Seoul | 135-280 | South Korea |
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| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003233 | Conjunctivitis, Allergic |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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| ID | Term |
|---|---|
| D000069559 | Loteprednol Etabonate |
| C009935 | prednisolone acetate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Prednisolone Acetate 1% Oph Susp | Drug | Ocular administration of study drug. at least once within any indication of the label. |
|
|
Signs and symptoms of giant papillary conjunctivitis: The results of the efficacy assessment will be evaluated according to the classification: improved, unchanged, worsened, impossible to assess. |
| 4 years |
| Post-operative inflammation | Treatment of post-operative inflammation following ocular surgery: The results of the final efficacy assessment will be evaluated according to the classification: improved, unchanged, worsened, impossible to assess. | 4 years |
| D007154 |
| Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |