An Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis

Allergic Conjunctivitis Clinical Trial

Official title:

An Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037179
• Other study ID #: C-09-050
• Status: Completed
• Phase: Phase 3
• First received: December 18, 2009
• Last updated: July 31, 2014
• Start date: February 2010
• Est. completion date: May 2010

Study information

• Verified date: July 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to assess safety and efficacy of long-term use of AL-4943A (Olopatadine Hydrochloride Ophthalmic Solution, 0.2%) in patients with allergic conjunctivitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Subjects must provide written consent.

• Subjects must have a diagnosis of allergic conjunctivitis.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Itching and/or hyperemia associated with diseases other than allergic conjunctivitis.

• Retinal detachment, diabetic retinopathy, or any progressive disease in posterior segment of the eye.

• Known history of ocular infection.

• Contact lens wear during study.

• Pregnant, nursing.

• Participation in another clinical study within 30 days of Informed Consent.

• Other protocol-defined exclusion criteria may apply.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

Locations

Country	Name	City	State
Japan	Investigational Center	Osaka-shi	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Itching Score by Visit	Ocular itching will be assessed by the subject and graded on a 6-point scale, where 0=did not occur and 5=virtually all the time over the past 3 days.	Up to Week 10	No
Primary	Mean Total Hyperemia Score by Visit	Ocular hyperemia (redness) will be assessed by the investigator. Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctival scores.	Up to Week 10	No
Secondary	Mean Subjective Symptoms by Visit		Up to Week 10	No