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

This study has been completed.
Sponsor:
Information provided by:
Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01363700
First received: May 30, 2011
Last updated: March 26, 2012
Last verified: March 2012
  Purpose

The purpose of the study is to demonstrate safety and efficacy of DE-114 ophthalmic solution compared to its Placebo and Olopatadine hydrochloride 0.1% ophthalmic solution in patients with allergic conjunctivitis.


Condition Intervention Phase
Allergic Conjunctivitis
Drug: DE-114 ophthalmic solution
Drug: Placebo ophthalmic solution
Drug: Olopatadine Hydrochloride 0.1% Ophthalmic Solution
Phase 3

Study Type: Interventional
Official Title: Double-masked, Comparison Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3, Confirmatory Study -

Resource links provided by NLM:


Further study details as provided by Santen Pharmaceutical Co., Ltd.:

Arms Assigned Interventions
Experimental: 1 Drug: DE-114 ophthalmic solution
Placebo Comparator: 2 Drug: Placebo ophthalmic solution
Active Comparator: 3 Drug: Olopatadine Hydrochloride 0.1% Ophthalmic Solution

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Provided signed, written informed consent.
  • Has a positive result from an allergen-specific IgE antibody 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01363700

Locations
Japan
Santen study sites
Osaka, Japan
Sponsors and Collaborators
Santen Pharmaceutical Co., Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01363700     History of Changes
Other Study ID Numbers: 01141101
Study First Received: May 30, 2011
Last Updated: March 26, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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