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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01363700
First Posted: June 1, 2011
Last Update Posted: November 19, 2014
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.
Information provided by:
Santen Pharmaceutical Co., Ltd.
  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.:

Primary Outcome Measures:
  • Mean Ocular Itching Score Compared to Placebo Period1 [ Time Frame: Visit 5 (3, 5, and 10 minutes post-CAC) ]

    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.

    The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge .


  • Mean Hyperemia Score Compared to Placebo Period1 [ Time Frame: Visit 5 (5, 10, and 20 minutes post-CAC) ]

    A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores. Count unit was defined each eye.

    The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge .



Secondary Outcome Measures:
  • Mean Ocular Itching Score Compared to Olopatadine Period2 [ Time Frame: Visit 7 (3, 5, and 10 minutes post-CAC) ]

    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 on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch.

    The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge .


  • Mean Hyperemia Score Compared to Olopatadine Period2 [ Time Frame: Visit 7 (5, 10, and 20 minutes post-CAC) ]

    A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores.

    The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge .



Enrollment: 87
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: DE-114 ophthalmic solution
Other Name: Epinastine ophthalmic solution
Placebo Comparator: 2 Drug: Placebo ophthalmic solution
Active Comparator: 3 Drug: Olopatadine Hydrochloride 0.1% Ophthalmic Solution

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
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): NCT01363700


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01363700     History of Changes
Other Study ID Numbers: 01141101
First Submitted: May 30, 2011
First Posted: June 1, 2011
Results First Submitted: October 22, 2014
Results First Posted: November 5, 2014
Last Update Posted: November 19, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
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