An Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Conjunctivitis
Intervention: Olopatadine Hydrochloride Ophthalmic Solution, 0.2% (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Alcon Research
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.
Clinical Details
Official title: An Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Mean Itching Score by VisitMean Total Hyperemia Score by Visit
Secondary outcome: Mean Subjective Symptoms by Visit
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Investigational Center, Osaka-shi, Osaka 532-0003, Japan
Additional Information
Starting date: February 2010
Last updated: July 31, 2014
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