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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

Primary Purpose

Allergic Conjunctivitis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

CsA high dose

CsA low dose

Placebo

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Cyclosporine low dose , Prednisolone Acetate

Cyclosporine high dose, Prednisolone Acetate

Cyclosporine high dose

Cyclosporine low dose

Prednisolone Acetate

Placebo

Arm Description

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

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

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

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

Administration of a suspension of Prednisolone Acetate and Placebo

Administration of Placebo

Outcomes

Primary Outcome Measures

Diary assessment of signs and symptoms of ocular allergy

Patient-reported ocular itching and redness

Secondary Outcome Measures

Diary and office assessments of various ocular and nasal allergy signs and symptoms

Patient-reported ocular itching and redness, lid swelling, tearing and nasal itching Investigator assessments of ocular redness and chemosis

Safety

Ocular tolerance and adverse events

Full Information

NCT ID

NCT01120132

First Posted

April 29, 2010

Last Updated

March 8, 2012

Sponsor

Fovea Pharmaceuticals SA

1. Study Identification

Unique Protocol Identification Number

NCT01120132

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fovea Pharmaceuticals SA

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Conjunctivitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

716 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cyclosporine low dose , Prednisolone Acetate

Arm Type

Experimental

Arm Description

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

Arm Title

Cyclosporine high dose, Prednisolone Acetate

Arm Type

Experimental

Arm Description

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

Arm Title

Cyclosporine high dose

Arm Type

Experimental

Arm Description

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

Arm Title

Cyclosporine low dose

Arm Type

Experimental

Arm Description

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

Arm Title

Prednisolone Acetate

Arm Type

Active Comparator

Arm Description

Administration of a suspension of Prednisolone Acetate and Placebo

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Administration of Placebo

Intervention Type

Drug

Intervention Name(s)

CsA high dose

Intervention Description

Solution of Cyclosporine (high dose) administered during 28 days

Intervention Type

Drug

Intervention Name(s)

CsA low dose

Intervention Description

Solution of Cyclosporine (low dose) administered during 28 days

Intervention Type

Drug

Intervention Name(s)

Intervention Description

Suspension of Prednisolone Acetate administered during 28 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo solution administered during 28 days

Primary Outcome Measure Information:

Title

Diary assessment of signs and symptoms of ocular allergy

Description

Patient-reported ocular itching and redness

Time Frame

During the 28 days of treatment

Secondary Outcome Measure Information:

Title

Diary and office assessments of various ocular and nasal allergy signs and symptoms

Description

Patient-reported ocular itching and redness, lid swelling, tearing and nasal itching Investigator assessments of ocular redness and chemosis

Time Frame

During 28 days of treatment

Title

Safety

Description

Ocular tolerance and adverse events

Time Frame

During the 28 days of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie-Louise Jacques, MD MBA

Organizational Affiliation

Fovea Pharmaceuticals SA

Official's Role

Study Chair

Facility Information:

Facility Name

ORA

City

Andover

State/Province

Massachusetts

ZIP/Postal Code

01810

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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