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

• Diary and office assessments of various ocular and nasal allergy signs and symptoms [ Time Frame: During 28 days of treatment ] [ Designated as safety issue: No ]

  Patient-reported ocular itching and redness, lid swelling, tearing and nasal itching

  Investigator assessments of ocular redness and chemosis

• Safety [ Time Frame: During the 28 days of treatment ] [ Designated as safety issue: Yes ]
  Ocular tolerance and adverse events

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.

• Drug: CsA high dose
  Solution of Cyclosporine (high dose) administered during 28 days
• Drug: CsA low dose
  Solution of Cyclosporine (low dose) administered during 28 days
• Drug: PA
  Suspension of Prednisolone Acetate administered during 28 days
• Drug: Placebo
  Placebo solution administered during 28 days

• Experimental: Cyclosporine low dose , Prednisolone Acetate
  Administration of a solution of Cyclosporine (low dose) and a suspension of Prednisolone Acetate
  Interventions:

  • Drug: CsA low dose
  • Drug: PA
• Experimental: Cyclosporine high dose, Prednisolone Acetate
  Administration of a solution of Cyclosporine (high dose) and a suspension of Prednisolone Acetate
  Interventions:

  • Drug: CsA high dose
  • Drug: PA
• Experimental: Cyclosporine high dose
  Administration of a solution of Cyclosporine (high dose) and Placebo
  Interventions:

  • Drug: CsA high dose
  • Drug: Placebo
• Experimental: Cyclosporine low dose
  Administration of a solution of Cyclosporine (low dose) and Placebo
  Interventions:

  • Drug: CsA low dose
  • Drug: Placebo
• Active Comparator: Prednisolone Acetate
  Administration of a suspension of Prednisolone Acetate and Placebo
  Intervention: Drug: PA
• Placebo Comparator: Placebo
  Administration of Placebo
  Intervention: Drug: Placebo

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)