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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01037179
First received: December 18, 2009
Last updated: January 11, 2012
Last verified: January 2012
  Purpose

The objective of this study is to assess safety and efficacy of long-term use of AL-4943A Ophthalmic Solution, 0.2% in patients with allergic conjunctivitis.


Condition Intervention Phase
Allergic Conjunctivitis
Drug: AL-4943A (olopatidine 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:
  • Itching [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Ocular itching, as assessed by the subject, was graded on a 6-point scale: 0=did not occur; 1=once; 2=at least once on two days; 3=at least once every day; 4=two or more time every day; 5=virtually all the time over the past three days.

  • Hyperemia [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Ocular hyperemia (redness) was assessed by the investigator for the palpebral conjunctiva and the bulbar conjunctiva. Hyperemia was assessed using a 6-point pictorial scale ranging from 0 (representing no hyperemia) to 5. The palpebral and bulbar conjunctival scores were summed together for a total hyperemia score.


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: Olopatadine 0.2%
Two drops instilled into both eyes, twice daily, for 10 weeks
Drug: AL-4943A (olopatidine 0.2%)
Ophthalmic solution containing olopatidine 2.22 mg 0.2%) in 1 mL.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Twelve years of age or older, either sex.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037179

Locations
Japan
Makoto Ando, MD
Osaka-shi, Osaka, Japan, 532-0003
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01037179     History of Changes
Other Study ID Numbers: C-09-050
Study First Received: December 18, 2009
Last Updated: January 11, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare
United States: Food and Drug Administration

Keywords provided by Alcon Research:
Allergies - Ocular

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Olopatadine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014