A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Administration of FOV1101-00 (Cyclosporine Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle in Patients With Mild Ongoing Ocular Allergic Inflammation
Overview
- Phase
- Phase 2
- Intervention
- CsA low dose
- Conditions
- Allergic Conjunctivitis
- Sponsor
- Fovea Pharmaceuticals SA
- Enrollment
- 716
- Locations
- 1
- Primary Endpoint
- Diary assessment of signs and symptoms of ocular allergy
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •history of ocular allergies and a positive skin test reaction to perennial allergens within the past 24 months and a history of chronic eye irritation
- •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
- •active ocular infection; preauricular lymphadenopathy or ocular condition that could affect study; glaucoma or abnormal intraocular pressure; ocular surgery within past 3 months; history of asthma, pregnancy or nursing
- •contraindications or known allergies to the study drug(s)
Arms & Interventions
Cyclosporine low dose , Prednisolone Acetate
Administration of a solution of Cyclosporine (low dose) and a suspension of Prednisolone Acetate
Intervention: CsA low dose
Cyclosporine low dose , Prednisolone Acetate
Administration of a solution of Cyclosporine (low dose) and a suspension of Prednisolone Acetate
Intervention: PA
Cyclosporine high dose, Prednisolone Acetate
Administration of a solution of Cyclosporine (high dose) and a suspension of Prednisolone Acetate
Intervention: CsA high dose
Cyclosporine high dose, Prednisolone Acetate
Administration of a solution of Cyclosporine (high dose) and a suspension of Prednisolone Acetate
Intervention: PA
Cyclosporine high dose
Administration of a solution of Cyclosporine (high dose) and Placebo
Intervention: CsA high dose
Cyclosporine high dose
Administration of a solution of Cyclosporine (high dose) and Placebo
Intervention: Placebo
Cyclosporine low dose
Administration of a solution of Cyclosporine (low dose) and Placebo
Intervention: CsA low dose
Cyclosporine low dose
Administration of a solution of Cyclosporine (low dose) and Placebo
Intervention: Placebo
Prednisolone Acetate
Administration of a suspension of Prednisolone Acetate and Placebo
Intervention: PA
Placebo
Administration of Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Diary assessment of signs and symptoms of ocular allergy
Time Frame: During the 28 days of treatment
Patient-reported ocular itching and redness
Secondary Outcomes
- Diary and office assessments of various ocular and nasal allergy signs and symptoms(During 28 days of treatment)
- Safety(During the 28 days of treatment)