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

Alcon

Status and phase: Completed; Phase 3

Conditions: Allergic Conjunctivitis

Treatments: Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01037179

C-09-050

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

AL-4943A

Experimental group

Description:

Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, 2 drops instilled in each eye twice daily for 10 weeks

Treatment:

Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%