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

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: December 18, 2009
Last updated: July 31, 2014
Last verified: July 2014
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.

Condition Intervention Phase
Allergic Conjunctivitis
Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Itching Score by Visit [ Time Frame: 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 [ Time Frame: 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:
  • Mean Subjective Symptoms by Visit [ Time Frame: Up to Week 10 ]

Enrollment: 110
Study Start Date: February 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-4943A
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, 2 drops instilled in each eye twice daily for 10 weeks
Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
Other Name: PATADAY®


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01037179

Investigational Center
Osaka-shi, Osaka, Japan, 532-0003
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Alcon Research Identifier: NCT01037179     History of Changes
Other Study ID Numbers: C-09-050
Study First Received: December 18, 2009
Last Updated: July 31, 2014

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Pharmaceutical Solutions
Olopatadine Hydrochloride
Ophthalmic Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017