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Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)
This study has been completed.
Sponsored by: Alcon Research
Information provided by: Alcon Research
ClinicalTrials.gov Identifier: NCT00818805
  Purpose

To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal allergic conjunctivitis.


Condition Intervention Phase
Allergic Conjunctivitis
Drug: Olopatadine 0.1%
Drug: Tranilast 0.5%
Phase IV

MedlinePlus related topics: Hay Fever
Drug Information available for: Olopatadine Tranilast
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Crossover Assignment

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Change in ocular itching score in subjective symptom questionnaire [ Time Frame: 15-180 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in total score in ocular symptom questionnaire [ Time Frame: 15-180 min. ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Olopatadine 0.1%
Drug: Olopatadine 0.1%
one drop
2: Placebo Comparator
Tranilast ophthalmic solution 0.5%
Drug: Tranilast 0.5%
one drop

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age/Gender: males and females aged >20 to < 65 years (at the time of obtaining consent).
  2. Positive cases in whom blood specific IgE antibody quantification against cedar pollen showed class 2-6 in a health checkup conducted within the past 3 years.
  3. Cases who were diagnosed as patients with seasonal allergic conjunctivitis and were judged eligible as subjects of the said study by the investigator or co-investigator from the results of medical examination conducted on the day of the study or prior to it.
  4. Cases who gave consent on study participation of their own free will in writing, with understanding the contents of the said study.

Exclusion Criteria:

  1. Cases with an ocular disease that requires treatment other than allergic conjunctivitis.
  2. Cases with an inflammatory ocular disease in the external/anterior part of the eye that may affect drug efficacy evaluation.
  3. Cases with a respiratory disease such as bronchial asthma other than allergic rhinitis.
  4. Cases with past history of anaphylaxis.
  5. Cases with past history of hypersensitivity to olopatadine hydrochloride/tranilast.
  6. Cases undergoing immunotherapy (hyposensitization therapy; modulated therapy).
  7. Patients who are pregnant, lactating women, or may be pregnant, or cases wishing to be pregnant during the study period.
  8. Other cases who are judged ineligible for participation in the main study by the doctor in charge of the study.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: ( Takahiro Nakagawa )
Study ID Numbers: AL-292ET
Study First Received: January 7, 2009
Last Updated: January 7, 2009
ClinicalTrials.gov Identifier: NCT00818805  
Health Authority: Japan: Institutional Review Board

Keywords provided by Alcon Research:
conjunctivitis

Study placed in the following topic categories:
Otorhinolaryngologic Diseases
Conjunctivitis, Allergic
Eye Diseases
SARS
Rhinitis
Conjunctivitis
Olopatadine
Conjunctival Diseases
Histamine
Tranilast
Hypersensitivity
Respiratory Tract Diseases
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Histamine phosphate
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neurotransmitter Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine Agents
Anti-Allergic Agents
Nose Diseases
Pharmacologic Actions
Histamine Antagonists
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Histamine H1 Antagonists
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Histamine H1 Antagonists, Non-Sedating
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009