Back to resultsAn Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis
Eligibility Criteria
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.
Sites / Locations
- Investigational Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AL-4943A
Arm Description
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, 2 drops instilled in each eye twice daily for 10 weeks
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Mean Subjective Symptoms by Visit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01037179
Brief Title
An Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis
Official Title
An Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AL-4943A
Arm Type
Experimental
Arm Description
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, 2 drops instilled in each eye twice daily for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
Other Intervention Name(s)
PATADAY®
Primary Outcome Measure Information:
Title
Mean Itching Score by Visit
Description
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.
Time Frame
Up to Week 10
Title
Mean Total Hyperemia Score by Visit
Description
Ocular hyperemia (redness) will be assessed by the investigator. Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctival scores.
Time Frame
Up to Week 10
Secondary Outcome Measure Information:
Title
Mean Subjective Symptoms by Visit
Time Frame
Up to Week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Investigational Center
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
532-0003
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
An Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis
We'll reach out to this number within 24 hrs