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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00818805
• Collaborator: (none)
• Enrollment: 50
• Arms: 4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Allergic Conjunctivitis	Drug: Olopatadine 0.1%; Drug: Tranilast 0.5%; Drug: Placebo (Olopatadine); Drug: Placebo (Tranilast)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire [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

1. Change in Total Score in Ocular Symptom Questionnaire [15-180 min.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• 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

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00818805
• Other Study ID Numbers: AL-292ET
• First Posted: Jan 8, 2009
• Last Update Posted: Jun 4, 2012
• Last Verified: Mar 1, 2010

• Keywords provided by Alcon Research: conjunctivitis
• Additional relevant MeSH terms: Conjunctivitis; Conjunctivitis, Allergic; Olopatadine Hydrochloride; Tranilast

Study Results

Participant Flow

Recruitment Details	The recruitment period: May 21-31, 2008 Location: Samoncho Clinic
Pre-assignment Detail	The study was conducted using an Ohio chamber in two parts: 1) a proof-of concept pilot study designed to assess the appropriateness of the OHIO chamber to induce ocular symptoms. 2) a randomized, single-masked, placebo-controlled, cross-over study.

Arm/Group Title	Olopatadine 0.1% First, Then Tranilast Second	Tranilast 0.5% First, Then Olopatadine Second
Arm/Group Description	Patients received Olopatadine 0.1% one eye/ Placebo (Olopatadine) in contralateral eye first, then received Tranilast 0.5% one eye/ Placebo (Tranilast) in contralateral eye next	Patients received Tranilast 0.5% one eye/ Placebo (Tranilast) in contralateral eye first, then received Olopatadine 0.1% one eye/ Placebo (Olopatadine) in contralateral eye last.
Period Title: First Intervention
STARTED	25	25
COMPLETED	25	25
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	25	25
COMPLETED	25	25
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Entire Study Population
Arm/Group Description
Overall Participants	50
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	50 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	35 70%
Male	15 30%

Outcome Measures

1. Primary Outcome

Title	Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire
Description	Ocular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching.
Time Frame	0-180 minutes after entering the examination room

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Olopatadine 0.1% One Eye	Tranilast 0.5% One Eye	Placebo (Olopatadine)	Placebo (Tranilast)
Arm/Group Description	Olopatadine 0.1% in one eye in either the first or second period	Tranilast 0.5% in one eye in either the first or second period	Placebo (Olopatadine) in one eye in either the first or second period	Placebo (Tranilast) in one eye in either the first or second period
Measure Participants	50	50	50	50
15 minutes	0.19 (0.47)	0.11 (0.46)	0.06 (0.33)	0.08 (0.44)
30 minutes	0.44 (0.61)	0.25 (0.50)	0.33 (0.53)	0.28 (0.51)
45 minutes	0.50 (0.70)	0.36 (0.68)	0.50 (0.65)	0.56 (0.69)
60 minutes	0.67 (0.76)	0.50 (0.74)	0.75 (0.69)	0.61 (0.73)
75 minutes	0.81 (0.82)	0.67 (0.79)	0.92 (0.81)	0.78 (0.76)
90 minutes	0.92 (0.81)	0.86 (0.72)	0.92 (0.69)	0.94 (0.75)
105 minutes	0.94 (0.58)	0.86 (0.72)	1.03 (0.70)	0.97 (0.81)
120 minutes	1.03 (0.65)	1.03 (0.70)	1.19 (0.67)	1.08 (0.81)
135 minutes	1.17 (0.70)	1.14 (0.72)	1.33 (0.72)	1.19 (0.82)
150 minutes	1.25 (0.77)	1.14 (0.76)	1.36 (0.64)	1.25 (0.77)
165 minutes	1.28 (0.78)	1.14 (0.76)	1.39 (0.64)	1.33 (0.76)
180 minutes	1.39 (0.77)	1.39 (0.77)	1.44 (0.69)	1.47 (0.88)

2. Secondary Outcome

Title	Change in Total Score in Ocular Symptom Questionnaire
Time Frame	15-180 min.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Olopatadine 0.1% One Eye		Tranilast 0.5% One Eye		Placebo (Olopatadine) One Eye		Placebo (Tranilast) One Eye
Arm/Group Description	Olopatadine 0.1% in one eye in either the first or second period		Tranilast 0.5% in one eye in either the first or second period		Placebo (Olopatadine) in one eye in either the first or second period		Placebo (Tranilast) in one eye in either the first or second period
All Cause Mortality
	Olopatadine 0.1% One Eye		Tranilast 0.5% One Eye		Placebo (Olopatadine) One Eye		Placebo (Tranilast) One Eye
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Olopatadine 0.1% One Eye		Tranilast 0.5% One Eye		Placebo (Olopatadine) One Eye		Placebo (Tranilast) One Eye
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)		0/50 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Olopatadine 0.1% One Eye		Tranilast 0.5% One Eye		Placebo (Olopatadine) One Eye		Placebo (Tranilast) One Eye
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)		0/50 (0%)		0/50 (0%)

Limitations/Caveats

Technical problems with measurement leading to unreliable or uninterpretable data.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.