Study Evaluating the Efficacy of Administration of Cyclosporine (Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle in Patients With Allergic Conjunctivitis
NCT ID: NCT01120132
Last Updated: 2012-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
716 participants
INTERVENTIONAL
2010-05-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cyclosporine low dose , Prednisolone Acetate
Administration of a solution of Cyclosporine (low dose) and a suspension of Prednisolone Acetate
CsA low dose
Solution of Cyclosporine (low dose) administered during 28 days
PA
Suspension of Prednisolone Acetate administered during 28 days
Cyclosporine high dose, Prednisolone Acetate
Administration of a solution of Cyclosporine (high dose) and a suspension of Prednisolone Acetate
CsA high dose
Solution of Cyclosporine (high dose) administered during 28 days
PA
Suspension of Prednisolone Acetate administered during 28 days
Cyclosporine high dose
Administration of a solution of Cyclosporine (high dose) and Placebo
CsA high dose
Solution of Cyclosporine (high dose) administered during 28 days
Placebo
Placebo solution administered during 28 days
Cyclosporine low dose
Administration of a solution of Cyclosporine (low dose) and Placebo
CsA low dose
Solution of Cyclosporine (low dose) administered during 28 days
Placebo
Placebo solution administered during 28 days
Prednisolone Acetate
Administration of a suspension of Prednisolone Acetate and Placebo
PA
Suspension of Prednisolone Acetate administered during 28 days
Placebo
Administration of Placebo
Placebo
Placebo solution administered during 28 days
Interventions
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CsA high dose
Solution of Cyclosporine (high dose) administered during 28 days
CsA low dose
Solution of Cyclosporine (low dose) administered during 28 days
PA
Suspension of Prednisolone Acetate administered during 28 days
Placebo
Placebo solution administered during 28 days
Eligibility Criteria
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Inclusion Criteria
* visual acuity score ≥ 0.60 (EDTS)
* negative urine pregnancy test for female patients, and use of adequate birth control throughout the study period.
Exclusion Criteria
* contraindications or known allergies to the study drug(s)
18 Years
ALL
No
Sponsors
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Fovea Pharmaceuticals SA
INDUSTRY
Responsible Party
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Principal Investigators
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Marie-Louise Jacques, MD MBA
Role: STUDY_CHAIR
Fovea Pharmaceuticals SA
Locations
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ORA
Andover, Massachusetts, United States
Countries
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Other Identifiers
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10-003-03
Identifier Type: OTHER
Identifier Source: secondary_id
FOV1101/CLIN202
Identifier Type: -
Identifier Source: org_study_id
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