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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

F

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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