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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fovea Pharmaceuticals SA
ClinicalTrials.gov Identifier:
NCT01120132
First received: April 29, 2010
Last updated: March 8, 2012
Last verified: March 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014