We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov Menu

Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 8, 2009
Last Update Posted: June 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
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 (Participant)
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 ]
    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. ]

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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: Alcon Research
ClinicalTrials.gov Identifier: NCT00818805     History of Changes
Other Study ID Numbers: AL-292ET
First Submitted: January 7, 2009
First Posted: January 8, 2009
Results First Submitted: December 3, 2009
Results First Posted: March 15, 2010
Last Update Posted: June 4, 2012
Last Verified: March 2010

Keywords provided by Alcon Research:

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Ophthalmic Solutions
Olopatadine Hydrochloride
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Platelet Aggregation Inhibitors