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Efficacy Study to Evaluate the Effectiveness of 3 Concentrations of SAR 1118 in Allergic Conjunctivitis

This study has been completed.
Sponsor:
Information provided by:
SARcode Bioscience
ClinicalTrials.gov Identifier:
NCT00882687
First received: April 15, 2009
Last updated: May 12, 2009
Last verified: May 2009
History of Changes
  Purpose

The purpose of this study is to determine whether SAR 1118 at three different concentrations, compared to placebo, is effective in the prevention of the signs and symptoms of allergic conjunctivitis


Condition Intervention Phase
Allergic Conjunctivitis
 Drug: SAR 1118
Other: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2, Single Center, Randomized, Double-Masked and Placebo Controlled Study Evaluating the Efficacy of Three Different Concentrations (0.1, 1.0, 5.0%) of SAR 1118 Ophthalmic Solution in a Modified Conjunctival Allergen Challenge (CAC) Model

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Further study details as provided by SARcode Bioscience:

Primary Outcome Measures:
  • Ocular itching and conjunctival redness at defined timepoints. [ Time Frame: Visit 4 and 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability in subjects with allergic conjunctivitis. [ Time Frame: Visit 3, 4, 5 and 6 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.1% Drug: SAR 1118
Ophthalmic Solution
Experimental: 1.0% Drug: SAR 1118
Ophthalmic Solution
Experimental: 5.0% Drug: SAR 1118
Ophthalmic Solution
Placebo Comparator: Placebo Other: Placebo
Ophthalmic Solution

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent form and HIPAA document
  • Willing and able to comply with all study procedures
  • Be at least 18 years of age at the time of enrollment
  • 20/40 vision, or better, in each eye
  • History of ocular allergies, and a positive skin and ocular allergic reaction to allergens
  • A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period

Exclusion Criteria:

  • Preauricular lymphadenopathy or any ocular condition that could affect study parameters (particularly, glaucoma, diabetic retinopathy, clinically significant blepharitis, follicular conjunctivitis and iritis)
  • Have had any ocular infection within the last 30 days
  • A positive diagnosis of moderate to severe dry eye syndrome (i.e., requiring daily use of artificial tears)
  • Any significant illness that could be expected to interfere with study parameters
  • Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye
  • Use of any investigational product or device within one month prior to Visit 1 or during the study period
  • Concomitant use of any prohibited medication (antihistamines, corticosteroids, all ocular medications or anti-allergic therapies) during the trial or within the washout period
  • Any blood donation or significant loss of blood within 56 days of Visit 1
  • Any history of autoimmune disease, immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti‑HAV IgM), or organ or bone marrow transplant. Any known history of iritis/uveitis, glaucoma, or other chronic ophthalmologic disorder other than allergic conjunctivitis
  • History of laser‑assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to Visit 1, and/or any other ocular surgical procedure within 3 months prior to Visit 1
  • Known history of alcohol abuse and/or drug abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882687

Locations
United States, Massachusetts
Ora
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
SARcode Bioscience
Investigators
Principal Investigator: Gail Torkildsen, MD ORA, Inc.
  More Information

No publications provided

Responsible Party: Director of Clinical Operations, SARcode
ClinicalTrials.gov Identifier: NCT00882687     History of Changes
Other Study ID Numbers: 1118-ACJ-100
Study First Received: April 15, 2009
Last Updated: May 12, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013