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A Study Of The Safety And Effectiveness Of A New Treatment For Allergic Conjunctivitis

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Alimera Sciences
ClinicalTrials.gov Identifier:
NCT00375596
First received: September 12, 2006
Last updated: January 31, 2012
Last verified: January 2012

September 12, 2006
January 31, 2012
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Complete list of historical versions of study NCT00375596 on ClinicalTrials.gov Archive Site
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A Study Of The Safety And Effectiveness Of A New Treatment For Allergic Conjunctivitis
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This study will evaluate the safety and efficacy of a new allergy medication

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Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Allergic Conjunctivitis
Drug: Ketotifen/vasoconstrictor
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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Inclusion Criteria:

  • Be at least 6 years of age, of any race, or either gender.
  • Have a positive allergic history of ocular allergies and a positive skin test reaction to cat hair/dander, ragweed, tree and/or grass pollen within the past 24 months.
  • Have a calculated best-corrected visual acuity of 0.6 logMar or better in each eye as measured using an ETDRS chart.
  • Positive bilateral CAC reaction at Visit 1 & 2.

Exclusion Criteria:

  • Have any known contraindications, allergies, or sensitivities to the use of any of the study medications, or their components.
  • Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
  • Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the baseline slit-lamp exam of any visit
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00375596
C-02-06-001
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Alimera Sciences
Alimera Sciences
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Alimera Sciences
January 2012

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