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

Fovea Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Allergic Conjunctivitis

Treatments: Drug: CsA high dose; Drug: CsA low dose; Drug: Placebo; Drug: PA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01120132

FOV1101/CLIN202

10-003-03 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 716 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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716 participants in 6 patient groups, including a placebo group

Cyclosporine low dose , Prednisolone Acetate

Experimental group

Description:

Administration of a solution of Cyclosporine (low dose) and a suspension of Prednisolone Acetate

Treatment:

Drug: PA

Drug: CsA low dose

Cyclosporine high dose, Prednisolone Acetate

Experimental group

Description:

Administration of a solution of Cyclosporine (high dose) and a suspension of Prednisolone Acetate

Treatment:

Drug: PA

Drug: CsA high dose

Cyclosporine high dose

Experimental group

Description:

Administration of a solution of Cyclosporine (high dose) and Placebo

Treatment:

Drug: Placebo

Drug: CsA high dose

Cyclosporine low dose

Experimental group

Description:

Administration of a solution of Cyclosporine (low dose) and Placebo

Treatment:

Drug: Placebo

Drug: CsA low dose

Prednisolone Acetate

Active Comparator group

Description:

Administration of a suspension of Prednisolone Acetate and Placebo

Treatment:

Drug: PA

Placebo

Placebo Comparator group

Description:

Administration of Placebo

Treatment:

Drug: Placebo