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This is a phase 2 study that will consist of 4 visits over a 5 week period. Drug will be evaluated using the conjunctival allergen challenge model of allergic conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Ketotifen 4.0% Patch |
|
| 2 | Placebo Comparator | Placebo Patch |
|
| 3 | Active Comparator | Pataday(TM) |
|
| 4 | Placebo Comparator | Placebo eye drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketotifen 4.0% Patch | Drug | This investigational drug is a transdermal patch indicated to treat allergic conjunctivitis. Application is intended for overnight wear between 8-10 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular itching and bulbar conjunctival redness | Visit 3 and Visit 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular: Ciliary, episcleral, and inferior palpebral conjunctival redness; chemosis; lid swelling; tearing; ocular mucous discharge | Visit 3 and Visit 4 | |
| Nasal: Rhinorrhea; ear or palate pruritis; nasal pruritis; nasal congestion; and a composite score of all nasal symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail Torkildsen, MD | ORA, Inc. | Principal Investigator |
| TBD TBD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ora | Andover | Massachusetts | 01810 | United States |
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| Placebo | Drug | The control is a placebo patch that contains only the inactive ingredients of ketotifen. |
|
| Olopatadine 0.2% | Drug | 1 gtt/eye on two separate occasions |
|
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| Artificial tears | Drug | 1 gtt/eye on two separate occasions |
|
| Visit 3 and Visit 4 |
| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007665 | Ketotifen |
| D057968 | Transdermal Patch |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004864 | Equipment and Supplies |
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |
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