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

This study has been completed.
Information provided by:
Santen Pharmaceutical Co., Ltd. Identifier:
First received: May 30, 2011
Last updated: October 16, 2014
Last verified: October 2014

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.:

Primary Outcome Measures:
  • Mean Ocular itching score compared to Placebo [ Time Frame: Visit 5 (3, 5, and 10 minutes post-CAC) ] [ Designated as safety issue: No ]
    A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge and graded on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch. Count unit was defined each eye.

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


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

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.
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Please refer to this study by its identifier: NCT01363700

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

No publications provided Identifier: NCT01363700     History of Changes
Other Study ID Numbers: 01141101
Study First Received: May 30, 2011
Last Updated: October 16, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
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 processed this record on October 21, 2014