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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.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00818805
First received: January 7, 2009
Last updated: May 29, 2012
Last verified: March 2010
  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%
Drug: Placebo (Olopatadine)
Drug: Placebo (Tranilast)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire [ Time Frame: 0-180 minutes after entering the examination room ] [ Designated as safety issue: No ]
    Ocular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching.


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
Experimental: Olopatadine 0.1% one eye
Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye
Drug: Olopatadine 0.1%
one drop in one eye
Experimental: Tranilast 0.5% one eye
Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye
Drug: Tranilast 0.5%
one drop in one eye
Placebo Comparator: Placebo (Olopatadine)
Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye
Drug: Placebo (Olopatadine)
one drop in contralateral eye
Placebo Comparator: Placebo (Tranilast)
Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye
Drug: Placebo (Tranilast)
one drop in contralateral eye

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00818805     History of Changes
Other Study ID Numbers: AL-292ET
Study First Received: January 7, 2009
Results First Received: December 3, 2009
Last Updated: May 29, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Alcon Research:
conjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Rhinitis, Allergic, Seasonal
Conjunctival Diseases
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Rhinitis
Olopatadine
Ophthalmic Solutions
Tranilast
Analgesics
Analgesics, Non-Narcotic
Anti-Allergic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Hematologic Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating

ClinicalTrials.gov processed this record on November 24, 2014