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This is a phase 2 study that will consist of 3 visits during a 3 week period conducted at up to 5 sites. The purpose of this study is to determine how effective the combination of Pred Mild® and FOV1101-00 is compared to either Pred Forte® alone or to vehicle alone in the prevention of eye allergies. Study subjects will be randomized to one of the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | FOV1101-00 concentration 1 and Prednisolone Acetate 0.12% (Pred Mild®) |
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| 2 | Experimental | FOV1101-00 concentration 2 and Prednisolone Acetate 0.12% (Pred Mild®) |
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| 3 | Experimental | Vehicle of FOV1101-00 and Prednisolone Acetate 1% (Pred Forte®) |
|
| 4 | Placebo Comparator | Vehicle of FOV1101-00 and vehicle of FOV1101-00 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone Acetate 0.12% (Pred Mild®) | Drug | Indicated for the treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva, cornea, and sclera (including chemical and thermal burns). Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Allergic signs and symptoms Diary Scores | Between V2 and V3 |
| Measure | Description | Time Frame |
|---|---|---|
| Various ocular and nasal allergic diary scores | Between V2 and V3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Philippe Combal, PharmD | Fovea Pharmaceuticals SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ora | Andover | Massachusetts | 01810 | United States |
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| FOV1101-00 | Drug | This investigational drug is a low dose cyclosporine (also known as cyclosporine A; CsA) formulation for topical ocular administration. FOV1101-00 is presented as a solution for topical ophthalmic administration in two strengths, concentration 1 or concentration 2 w/v cyclosporine in citrate buffered aqueous vehicle. Application is intended as four times per day. |
|
| Prednisolone Acetate 1% (Pred Forte®) | Drug | PRED FORTE® is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue therapy prematurely. |
|
| Placebo | Drug | The vehicle is an eye drop that contains only the inactive ingredients of FOV1101-00. |
|
| 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 |
|---|---|
| C009935 | prednisolone acetate |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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