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This study will investigate the safety and efficacy of olopatadine hydrochloride / ketorolac tromethamine fixed dose combination ophthalmic solution compared with olopatadine hydrochloride ophthalmic solution in patients with seasonal allergic conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution |
|
| 2 | Active Comparator | olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution | Drug | One drop of olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution administered to each eye, twice daily for 21 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching | Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Hyperemia | Day 21 | |
| Chemosis | Day 21 | |
| Ocular mucous discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangalore | Karnataka | India |
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| olopatadine hydrochloride 0.1% ophthalmic solution | Drug | One drop of olopatadine hydrochloride 0.1% ophthalmic solution administered to each eye, twice daily for 21 days. |
|
|
| Day 21 |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069605 | Olopatadine Hydrochloride |
| D020911 | Ketorolac Tromethamine |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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