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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014