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A Long-term Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01363713
Recruitment Status : Completed
First Posted : June 1, 2011
Results First Posted : September 23, 2014
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):
Santen Pharmaceutical Co., Ltd.

Study Description
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Brief Summary:
Safety and efficacy of DE-114 ophthalmic solution will be evaluated in patients with allergic conjunctivitis, in an open-label, multicenter study.

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: DE-114 ophthalmic solution Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Official Title: A Long-term Open-label Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3 -
Actual Primary Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pink Eye

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: DE-114 ophthalmic solution


Outcome Measures
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Primary Outcome Measures :
  1. Change in Ocular Itching Score by Visit [ Time Frame: From baseline to 8-week ]

    Change from baseline in the average of Ocular itching score over the past 3 days. Ocular itching was assessed by the subject and graded on a 5 points scale of 0-4 (0=no itching, 4=incapacitating itch).

    The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined.



Other Outcome Measures:
  1. Change in Palpebral Hyperemia Score by Visit [ Time Frame: From baseline to 8-week ]

    Change from baseline of palpebral hyperemia score. Palpebral hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe).

    The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined.


  2. Change in Bulbar Conjunctiva Hyperemia Score by Visit [ Time Frame: From baseline to 8-week ]

    Change from baseline of bulbar conjunctiva hyperemia score. Bulbar conjunctiva hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe).

    The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined.



Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Provided signed, written informed consent.
  • Has a positive result from a Type I allergy test.
  • If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

Exclusion Criteria:

  • Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
  • Presence of any abnormality or significant illness that could be expected to interfere with the study.
Contacts and Locations
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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): NCT01363713


Locations
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Japan
Santen study sites
Osaka, Japan
Sponsors and Collaborators
Santen Pharmaceutical Co., Ltd.
More Information
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Responsible Party: Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01363713    
Other Study ID Numbers: 01141102
First Posted: June 1, 2011    Key Record Dates
Results First Posted: September 23, 2014
Last Update Posted: October 6, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Ophthalmic Solutions
Pharmaceutical Solutions