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AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis

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ClinicalTrials.gov Identifier: NCT02161146
Recruitment Status : Completed
First Posted : June 11, 2014
Results First Posted : March 7, 2016
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate the safety and efficacy of AGN-229666 for the prevention of allergen-mediated conjunctivitis.

Condition or disease Intervention/treatment Phase
Conjunctivitis, Allergic Drug: AGN-229666 Drug: Vehicle to AGN-229666 Drug: Olopatadine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Actual Study Start Date : June 4, 2014
Actual Primary Completion Date : December 20, 2014
Actual Study Completion Date : December 20, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
Experimental: AGN-229666
One drop of AGN-229666 in each eye on Days 1 and 15.
Drug: AGN-229666
One drop of AGN-229666 in the eye on Days 1 and 15.

Placebo Comparator: Vehicle
One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
Drug: Vehicle to AGN-229666
One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.

Active Comparator: Olopatadine
One drop of olopatadine in each eye on Days 1 and 15.
Drug: Olopatadine
One drop of olopatadine in the eye on Days 1 and 15.
Other Name: Patanol®

AGN-229666/Olopatadine
One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
Drug: AGN-229666
One drop of AGN-229666 in the eye on Days 1 and 15.

Drug: Olopatadine
One drop of olopatadine in the eye on Days 1 and 15.
Other Name: Patanol®

AGN-229666/Vehicle
One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
Drug: AGN-229666
One drop of AGN-229666 in the eye on Days 1 and 15.

Drug: Vehicle to AGN-229666
One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.




Primary Outcome Measures :
  1. Ocular Itching Score [ Time Frame: Days 1 and 15 ]
    Ocular itching was assessed by the participant 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 5 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no itching) to 4.0=incapacitating itch with an irresistible urge to rub (worst). Data from Days 1 and 15 were pooled together and averaged.


Secondary Outcome Measures :
  1. Conjunctival Hyperemia Score [ Time Frame: Days 1 and 15 ]
    Hyperemia is the engorgement of the blood vessels (redness) of the eye. Ocular hyperemia was evaluated by the investigator 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 15 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no hyperemia) to 4.0=extremely severe (large, numerous dilated blood vessels characterized by severe deep red color). Data from Days 1 and 15 were pooled together and averaged.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Japanese patients living in Japan with a history of allergic conjunctivitis.

Exclusion Criteria:

  • Presence of active eye infection (bacterial, viral, or fungal)
  • History of an eye herpetic infection.

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): NCT02161146


Locations
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Japan
Tokyo, Japan
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
Publications:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02161146    
Other Study ID Numbers: 229666-006
First Posted: June 11, 2014    Key Record Dates
Results First Posted: March 7, 2016
Last Update Posted: April 17, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
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