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

NCT01037179 | Completed Phase 3

• 1 other identifier: C-09-050
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to Week 10

• 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.

  Up to Week 10

Secondary Outcomes (1)

• Mean Subjective Symptoms by Visit

  Up to Week 10

Study Arms (1)

AL-4943A

EXPERIMENTAL

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

Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

Interventions

Olopatadine Hydrochloride Ophthalmic Solution, 0.2% DRUG

Also known as: PATADAY®

AL-4943A

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must provide written consent.
• Subjects must have a diagnosis of allergic conjunctivitis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Investigational Center

Osaka, Osaka, 532-0003, Japan

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Olopatadine Hydrochloride

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2009
• First Posted: December 22, 2009
• Study Start: February 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 4, 2014

Record last verified: 2014-07

Locations

JP (1)