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| ID | Type | Description | Link |
|---|---|---|---|
| 10-003-03 | Other Identifier | ORA Inc |
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The purpose of this study is to determine the efficacy and safety of the administration of cyclosporine and prednisolone acetate compared to placebo in the treatment of allergic conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclosporine low dose , Prednisolone Acetate | Experimental | Administration of a solution of Cyclosporine (low dose) and a suspension of Prednisolone Acetate |
|
| Cyclosporine high dose, Prednisolone Acetate | Experimental | Administration of a solution of Cyclosporine (high dose) and a suspension of Prednisolone Acetate |
|
| Cyclosporine high dose | Experimental | Administration of a solution of Cyclosporine (high dose) and Placebo |
|
| Cyclosporine low dose | Experimental | Administration of a solution of Cyclosporine (low dose) and Placebo |
|
| Prednisolone Acetate | Active Comparator | Administration of a suspension of Prednisolone Acetate and Placebo |
|
| Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CsA high dose | Drug | Solution of Cyclosporine (high dose) administered during 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diary assessment of signs and symptoms of ocular allergy | Patient-reported ocular itching and redness | During the 28 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Diary and office assessments of various ocular and nasal allergy signs and symptoms | Patient-reported ocular itching and redness, lid swelling, tearing and nasal itching Investigator assessments of ocular redness and chemosis | During 28 days of treatment |
| Safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie-Louise Jacques, MD MBA | Fovea Pharmaceuticals SA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ORA | Andover | Massachusetts | 01810 | United States |
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| Placebo Comparator |
Administration of Placebo |
|
| CsA low dose | Drug | Solution of Cyclosporine (low dose) administered during 28 days |
|
| PA | Drug | Suspension of Prednisolone Acetate administered during 28 days |
|
| Placebo | Drug | Placebo solution administered during 28 days |
|
Ocular tolerance and adverse events |
| During the 28 days of treatment |
| 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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