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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

Information source: Fovea Pharmaceuticals SA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Allergic Conjunctivitis

Intervention: CsA high dose (Drug); CsA low dose (Drug); PA (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Fovea Pharmaceuticals SA

Official(s) and/or principal investigator(s):
Marie-Louise Jacques, MD MBA, Study Chair, Affiliation: Fovea Pharmaceuticals SA

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.

Clinical Details

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

Primary outcome: Diary assessment of signs and symptoms of ocular allergy

Secondary outcome:

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

Safety

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

ORA, Andover, Massachusetts 01810, United States
Additional Information

Starting date: May 2010
Last updated: March 8, 2012

Page last updated: August 23, 2015

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