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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
History of Changes
  Purpose

This study will evaluate the safety and efficacy of a new allergy medication


Condition Intervention Phase
Allergic Conjunctivitis
 Drug: Ketotifen/vasoconstrictor
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Further study details as provided by Alimera Sciences:

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alimera Sciences
ClinicalTrials.gov Identifier: NCT00375596     History of Changes
Other Study ID Numbers: C-02-06-001
Study First Received: September 12, 2006
Last Updated: January 31, 2012
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
Ketotifen
Vasoconstrictor Agents
Antipruritics
Dermatologic Agents
 Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013