Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: July 31, 2014
Last verified: July 2014
  Purpose

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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®

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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.
  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
Investigational Center
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: July 31, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2014