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

NCT00818805 | Completed Phase 4 Results

• 1 other identifier: AL-292ET
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Allergic Conjunctivitis

Keywords

conjunctivitis

Outcome Measures

Primary Outcomes (1)

• Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire

  Ocular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching.

  0-180 minutes after entering the examination room

Secondary Outcomes (1)

• Change in Total Score in Ocular Symptom Questionnaire

  15-180 min.

Study Arms (4)

Olopatadine 0.1% one eye

EXPERIMENTAL

Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye

Drug: Olopatadine 0.1%

Tranilast 0.5% one eye

EXPERIMENTAL

Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye

Drug: Tranilast 0.5%

Placebo (Olopatadine)

PLACEBO COMPARATOR

Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye

Drug: Placebo (Olopatadine)

Placebo (Tranilast)

PLACEBO COMPARATOR

Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye

Drug: Placebo (Tranilast)

Interventions

Olopatadine 0.1% DRUG

one drop in one eye

Olopatadine 0.1% one eye

Tranilast 0.5% DRUG

one drop in one eye

Tranilast 0.5% one eye

Placebo (Olopatadine) DRUG

one drop in contralateral eye

Placebo (Olopatadine)

Placebo (Tranilast) DRUG

one drop in contralateral eye

Placebo (Tranilast)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Conjunctivitis, Allergic; Conjunctivitis

Interventions

Olopatadine Hydrochloride; tranilast

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Technical problems with measurement leading to unreliable or uninterpretable data.

Results Point of Contact

• Title: Alcon Clinical
• Organization: Alcon Labs

medinfo@alconlabs.com

888.451.3937; 817.568.6725

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2009
• First Posted: January 8, 2009
• Study Start: July 1, 2008
• Primary Completion: July 1, 2008
• Last Updated: June 4, 2012
• Results First Posted: March 15, 2010

Record last verified: 2010-03