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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fovea Pharmaceuticals SA
ClinicalTrials.gov Identifier:
NCT01120132
First received: April 29, 2010
Last updated: March 8, 2012
Last verified: March 2012

April 29, 2010
March 8, 2012
May 2010
August 2010   (final data collection date for primary outcome measure)
Diary assessment of signs and symptoms of ocular allergy [ Time Frame: During the 28 days of treatment ] [ Designated as safety issue: No ]
Patient-reported ocular itching and redness
Same as current
Complete list of historical versions of study NCT01120132 on ClinicalTrials.gov Archive Site
  • Diary and office assessments of various ocular and nasal allergy signs and symptoms [ Time Frame: During 28 days of treatment ] [ Designated as safety issue: No ]

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

    Investigator assessments of ocular redness and chemosis

  • Safety [ Time Frame: During the 28 days of treatment ] [ Designated as safety issue: Yes ]
    Ocular tolerance and adverse events
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Allergic Conjunctivitis
  • 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
  • Experimental: Cyclosporine low dose , Prednisolone Acetate
    Administration of a solution of Cyclosporine (low dose) and a suspension of Prednisolone Acetate
    Interventions:
    • Drug: CsA low dose
    • Drug: PA
  • Experimental: Cyclosporine high dose, Prednisolone Acetate
    Administration of a solution of Cyclosporine (high dose) and a suspension of Prednisolone Acetate
    Interventions:
    • Drug: CsA high dose
    • Drug: PA
  • Experimental: Cyclosporine high dose
    Administration of a solution of Cyclosporine (high dose) and Placebo
    Interventions:
    • Drug: CsA high dose
    • Drug: Placebo
  • Experimental: Cyclosporine low dose
    Administration of a solution of Cyclosporine (low dose) and Placebo
    Interventions:
    • Drug: CsA low dose
    • Drug: Placebo
  • Active Comparator: Prednisolone Acetate
    Administration of a suspension of Prednisolone Acetate and Placebo
    Intervention: Drug: PA
  • Placebo Comparator: Placebo
    Administration of Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
716
August 2010
August 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01120132
FOV1101/CLIN202, 10-003-03
No
Fovea Pharmaceuticals SA
Fovea Pharmaceuticals SA
Not Provided
Study Chair: Marie-Louise Jacques, MD MBA Fovea Pharmaceuticals SA
Fovea Pharmaceuticals SA
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP