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

March 8, 2012 updated by: Fovea Pharmaceuticals SA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

716

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • Ora

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Administration of Placebo
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
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: PA
Suspension of Prednisolone Acetate administered during 28 days
Drug: CsA high dose
Solution of Cyclosporine (high dose) 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diary assessment of signs and symptoms of ocular allergy
Time Frame: During the 28 days of treatment
Patient-reported ocular itching and redness
During the 28 days of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diary and office assessments of various ocular and nasal allergy signs and symptoms
Time Frame: During 28 days of treatment

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

Investigator assessments of ocular redness and chemosis
During 28 days of treatment
Safety
Time Frame: During the 28 days of treatment
Ocular tolerance and adverse events
During the 28 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fovea Pharmaceuticals SA

Investigators

  • Study Chair: Marie-Louise Jacques, MD MBA, Fovea Pharmaceuticals SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

April 29, 2010

First Submitted That Met QC Criteria

May 7, 2010

First Posted (Estimate)

May 10, 2010

Study Record Updates

Last Update Posted (Estimate)

March 9, 2012

Last Update Submitted That Met QC Criteria

March 8, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOV1101/CLIN202
  • 10-003-03 (Other Identifier: ORA Inc)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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