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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

NCT01120132 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 716

Last updated 2012-03-09

No results posted yet for this study

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.

Conditions

  • Allergic Conjunctivitis

Interventions

DRUG

CsA high dose

Solution of Cyclosporine (high dose) administered during 28 days

DRUG

CsA low dose

Solution of Cyclosporine (low dose) administered during 28 days

DRUG

PA

Suspension of Prednisolone Acetate administered during 28 days

DRUG

Placebo

Placebo solution administered during 28 days

Sponsors & Collaborators

  • Fovea Pharmaceuticals SA

    lead INDUSTRY

Principal Investigators

  • Marie-Louise Jacques, MD MBA · Fovea Pharmaceuticals SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01120132 on ClinicalTrials.gov