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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Allergic Conjunctivitis	Drug: CsA high dose Drug: CsA low dose Drug: PA Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Pinkeye

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate Cyclosporine

U.S. FDA Resources

Further study details as provided by Fovea Pharmaceuticals SA:

Primary Outcome Measures:

Diary assessment of signs and symptoms of ocular allergy [ Time Frame: During the 28 days of treatment ] [ Designated as safety issue: No ]
Patient-reported ocular itching and redness

Secondary Outcome Measures:

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

Enrollment:	716
Study Start Date:	May 2010
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cyclosporine low dose , Prednisolone Acetate Administration of a solution of Cyclosporine (low dose) and a suspension of Prednisolone Acetate	Drug: CsA low dose Solution of Cyclosporine (low dose) administered during 28 days Drug: PA Suspension of Prednisolone Acetate administered during 28 days
Experimental: Cyclosporine high dose, Prednisolone Acetate Administration of a solution of Cyclosporine (high dose) and a suspension of Prednisolone Acetate	Drug: CsA high dose Solution of Cyclosporine (high dose) administered during 28 days Drug: PA Suspension of Prednisolone Acetate administered during 28 days
Experimental: Cyclosporine high dose Administration of a solution of Cyclosporine (high dose) and Placebo	Drug: CsA high dose Solution of Cyclosporine (high dose) administered during 28 days Drug: Placebo Placebo solution administered during 28 days
Experimental: Cyclosporine low dose Administration of a solution of Cyclosporine (low dose) and Placebo	Drug: CsA low dose Solution of Cyclosporine (low dose) administered during 28 days Drug: Placebo Placebo solution administered during 28 days
Active Comparator: Prednisolone Acetate Administration of a suspension of Prednisolone Acetate and Placebo	Drug: PA Suspension of Prednisolone Acetate administered during 28 days
Placebo Comparator: Placebo Administration of Placebo	Drug: Placebo Placebo solution administered during 28 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120132

Locations

United States, Massachusetts
ORA
Andover, Massachusetts, United States, 01810

Sponsors and Collaborators

Fovea Pharmaceuticals SA

Investigators

Study Chair:

Marie-Louise Jacques, MD MBA

Fovea Pharmaceuticals SA

More Information

No publications provided

Responsible Party:	Fovea Pharmaceuticals SA
ClinicalTrials.gov Identifier:	NCT01120132 History of Changes
Other Study ID Numbers:	FOV1101/CLIN202, 10-003-03
Study First Received:	April 29, 2010
Last Updated:	March 8, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cyclosporins
Cyclosporine
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate

Prednisolone phosphate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on May 23, 2013