Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)
This study has been completed.
Sponsor:
Alcon Research
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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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:
- Age/Gender: males and females aged >20 to < 65 years (at the time of obtaining consent).
- 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.
- 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.
- Cases who gave consent on study participation of their own free will in writing, with understanding the contents of the said study.
Exclusion Criteria:
- Cases with an ocular disease that requires treatment other than allergic conjunctivitis.
- Cases with an inflammatory ocular disease in the external/anterior part of the eye that may affect drug efficacy evaluation.
- Cases with a respiratory disease such as bronchial asthma other than allergic rhinitis.
- Cases with past history of anaphylaxis.
- Cases with past history of hypersensitivity to olopatadine hydrochloride/tranilast.
- Cases undergoing immunotherapy (hyposensitization therapy; modulated therapy).
- Patients who are pregnant, lactating women, or may be pregnant, or cases wishing to be pregnant during the study period.
- 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
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, Immediate Hypersensitivity Immune System Diseases Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Tranilast Olopatadine |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Histamine H1 Antagonists |
ClinicalTrials.gov processed this record on June 18, 2013