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

Phase 2

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: CsA high dose; Drug: CsA low dose; Drug: PA; Drug: Placebo

• Registration Number: NCT01120132
• Lead Sponsor: Fovea Pharmaceuticals SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-29
• Study Start: 2010-05
• Study First Submitted QC: 2010-05-07
• Study First Posted: 2010-05-10
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-08
• Last Update Posted: 2012-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 716

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cyclosporine high dose	CsA high dose	Administration of a solution of Cyclosporine (high dose) and Placebo
Cyclosporine high dose	Placebo	Administration of a solution of Cyclosporine (high dose) and Placebo
Cyclosporine low dose	CsA low dose	Administration of a solution of Cyclosporine (low dose) and Placebo
Cyclosporine low dose	Placebo	Administration of a solution of Cyclosporine (low dose) and Placebo
Prednisolone Acetate	PA	Administration of a suspension of Prednisolone Acetate and Placebo
Cyclosporine low dose , Prednisolone Acetate	CsA low dose	Administration of a solution of Cyclosporine (low dose) and a suspension of Prednisolone Acetate
Cyclosporine low dose , Prednisolone Acetate	PA	Administration of a solution of Cyclosporine (low dose) and a suspension of Prednisolone Acetate
Cyclosporine high dose, Prednisolone Acetate	CsA high dose	Administration of a solution of Cyclosporine (high dose) and a suspension of Prednisolone Acetate
Cyclosporine high dose, Prednisolone Acetate	PA	Administration of a solution of Cyclosporine (high dose) and a suspension of Prednisolone Acetate
Placebo	Placebo	Administration of Placebo

Primary Outcome Measures

Name	Time	Method
Diary assessment of signs and symptoms of ocular allergy	During the 28 days of treatment	Patient-reported ocular itching and redness

Secondary Outcome Measures

Name	Time	Method
Diary and office assessments of various ocular and nasal allergy signs and symptoms	During 28 days of treatment	Patient-reported ocular itching and redness, lid swelling, tearing and nasal itching; Investigator assessments of ocular redness and chemosis
Safety	During the 28 days of treatment	Ocular tolerance and adverse events

Trial Locations

Locations (1)

ORA; 🇺🇸 Andover, Massachusetts, United States