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

Allergic Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120132
• Other study ID #: FOV1101/CLIN202
• Secondary ID: 10-003-03
• Status: Completed
• Phase: Phase 2
• First received: April 29, 2010
• Last updated: March 8, 2012
• Start date: May 2010
• Est. completion date: August 2010

Study information

• Verified date: March 2012
• Source: Fovea Pharmaceuticals SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 716
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• CsA high dose
Solution of Cyclosporine (high dose) administered during 28 days
• CsA low dose
Solution of Cyclosporine (low dose) administered during 28 days
• PA
Suspension of Prednisolone Acetate administered during 28 days
• Placebo
Placebo solution administered during 28 days

Locations

Country	Name	City	State
United States	ORA	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Fovea Pharmaceuticals SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diary assessment of signs and symptoms of ocular allergy	Patient-reported ocular itching and redness	During the 28 days of treatment	No
Secondary	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	During 28 days of treatment	No
Secondary	Safety	Ocular tolerance and adverse events	During the 28 days of treatment	Yes