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| Sponsored by: |
Fovea Pharmaceuticals SA |
|---|---|
| Information provided by: | Fovea Pharmaceuticals SA |
| ClinicalTrials.gov Identifier: | NCT00833495 |
Purpose
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:
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Conjunctivitis |
Drug: Prednisolone Acetate 0.12% (Pred Mild®) Drug: FOV1101-00 Drug: Prednisolone Acetate 1% (Pred Forte®) Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
| Official Title: | A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Co-Administration of FOV1101-00 and Prednisolone Acetate 0.12% Compared to Prednisolone Acetate 1% Alone or Vehicle Alone in Patients With Mild Ongoing Ocular Allergic Inflammation |
| Estimated Enrollment: | 90 |
| Study Start Date: | January 2009 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
FOV1101-00 concentration 1 and Prednisolone Acetate 0.12% (Pred Mild®)
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Drug: Prednisolone Acetate 0.12% (Pred Mild®)
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.
Drug: FOV1101-00
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. |
|
2: Experimental
FOV1101-00 concentration 2 and Prednisolone Acetate 0.12% (Pred Mild®)
|
Drug: Prednisolone Acetate 0.12% (Pred Mild®)
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.
Drug: FOV1101-00
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. |
|
3: Experimental
Vehicle of FOV1101-00 and Prednisolone Acetate 1% (Pred Forte®)
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Drug: Prednisolone Acetate 1% (Pred Forte®)
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.
The vehicle is an eye drop that contains only the inactive ingredients of FOV1101-00.
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4: Placebo Comparator
Vehicle of FOV1101-00 and vehicle of FOV1101-00
|
Drug: Placebo
The vehicle is an eye drop that contains only the inactive ingredients of FOV1101-00.
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Fovea Pharmaceuticals SA ( Kerim Chitour, MD ) |
| Study ID Numbers: | 08-003-27 |
| Study First Received: | January 30, 2009 |
| Last Updated: | May 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00833495 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Anti-Inflammatory Agents Cyclosporine Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Tetrahydrozoline Cyclosporins Hormones Neuroprotective Agents Hypersensitivity Methylprednisolone Hemisuccinate |
Conjunctivitis, Allergic Antineoplastic Agents, Hormonal Eye Diseases Citric Acid Methylprednisolone acetate Conjunctivitis Glucocorticoids Conjunctival Diseases Inflammation Prednisolone Hypersensitivity, Immediate Citrate Peripheral Nervous System Agents |
|
Anti-Inflammatory Agents Methylprednisolone Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Neuroprotective Agents Hormones Hypersensitivity Pathologic Processes Therapeutic Uses Methylprednisolone Hemisuccinate Immune System Diseases Conjunctivitis, Allergic |
Antineoplastic Agents, Hormonal Eye Diseases Gastrointestinal Agents Methylprednisolone acetate Conjunctivitis Protective Agents Glucocorticoids Conjunctival Diseases Pharmacologic Actions Inflammation Autonomic Agents Prednisolone Hypersensitivity, Immediate Peripheral Nervous System Agents Central Nervous System Agents |
