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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT01037179

First received: December 18, 2009

Last updated: January 11, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	December 18, 2009
Last Updated Date	January 11, 2012
Start Date ^ICMJE	February 2010
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 11, 2012)	Itching [ Time Frame: 10 weeks ] [ Designated as safety issue: No ] Ocular itching, as assessed by the subject, was graded on a 6-point scale: 0=did not occur; 1=once; 2=at least once on two days; 3=at least once every day; 4=two or more time every day; 5=virtually all the time over the past three days. Hyperemia [ Time Frame: 10 weeks ] [ Designated as safety issue: No ] Ocular hyperemia (redness) was assessed by the investigator for the palpebral conjunctiva and the bulbar conjunctiva. Hyperemia was assessed using a 6-point pictorial scale ranging from 0 (representing no hyperemia) to 5. The palpebral and bulbar conjunctival scores were summed together for a total hyperemia score.
Original Primary Outcome Measures ^ICMJE (submitted: December 18, 2009)	Itching Score [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ] Total hyperemia score [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01037179 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE (submitted: December 18, 2009)	Subjective symptoms and Objective findings except for the primary efficacy variables [ Time Frame: Baseline to 10 weeks ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	An Open-label, Long-term Study, With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis
Official Title ^ICMJE	An Open-label, Long-term Study, With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis
Brief Summary	The objective of this study is to assess safety and efficacy of long-term use of AL-4943A Ophthalmic Solution, 0.2% in patients with allergic conjunctivitis.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Allergic Conjunctivitis
Intervention ^ICMJE	Drug: AL-4943A (olopatidine 0.2%) Ophthalmic solution containing olopatidine 2.22 mg 0.2%) in 1 mL.
Study Arm (s)	Experimental: Olopatadine 0.2% Two drops instilled into both eyes, twice daily, for 10 weeks Intervention: Drug: AL-4943A (olopatidine 0.2%)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	110
Completion Date	May 2010
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Twelve years of age or older, either sex. 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.
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT01037179
Other Study ID Numbers ^ICMJE	C-09-050
Has Data Monitoring Committee	No
Responsible Party	Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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