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

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ClinicalTrials.gov Identifier: NCT01037179
Recruitment Status : Completed
First Posted : December 22, 2009
Last Update Posted : August 4, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2% Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Pinkeye
U.S. FDA Resources

Arm Intervention/treatment
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®



Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. Mean Subjective Symptoms by Visit [ Time Frame: Up to Week 10 ]


Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037179


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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01037179     History of Changes
Other Study ID Numbers: C-09-050
First Posted: December 22, 2009    Key Record Dates
Last Update Posted: August 4, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Olopatadine Hydrochloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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