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Completed

NCT Number: NCT01120132

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

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.

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ORA

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CsA high dose

Drug

Solution of Cyclosporine (high dose) administered during 28 days

CsA low dose

Drug

Solution of Cyclosporine (low dose) administered during 28 days

PA

Drug

Suspension of Prednisolone Acetate administered during 28 days

Placebo

Drug

Placebo solution administered during 28 days

Primary outcomes

  1. Diary assessment of signs and symptoms of ocular allergy

    Time frame: During the 28 days of treatment

    Patient-reported ocular itching and redness

Secondary outcomes

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

    Time frame: During 28 days of treatment

    Patient-reported ocular itching and redness, lid swelling, tearing and nasal itching

    Investigator assessments of ocular redness and chemosis

  2. Safety

    Time frame: During the 28 days of treatment

    Ocular tolerance and adverse events

Sponsors and collaborators

Lead sponsor

Fovea Pharmaceuticals SA

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 10, 2010
Registry last updated
Mar 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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