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

Phase 3

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

• Registration Number: NCT01037179
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-12-18
• Study First Submitted QC: 2009-12-18
• Study First Posted: 2009-12-22
• Study Start: 2010-02
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2014-07
• Disposition First Submitted: 2014-07-28
• Disposition First Submitted QC: 2014-07-28
• Disposition First Posted: 2014-07-31
• Last Update Submitted: 2014-07-31
• Last Update Posted: 2014-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Subjects must provide written consent.
• Subjects must have a diagnosis of allergic conjunctivitis.
• Other protocol-defined inclusion criteria may apply.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AL-4943A	Olopatadine Hydrochloride Ophthalmic Solution, 0.2%	Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, 2 drops instilled in each eye twice daily for 10 weeks

Primary Outcome Measures

Name	Time	Method
Mean Itching Score by Visit	Up to Week 10	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	Up to Week 10	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

Name	Time	Method
Mean Subjective Symptoms by Visit	Up to Week 10

Trial Locations

Locations (1)

Investigational Center; 🇯🇵 Osaka-shi, Osaka, Japan