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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: November 5, 2014
Last verified: November 2014
  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) ] [ 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.

    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) ] [ Designated as safety issue: No ]

    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) ] [ 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 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) ] [ Designated as safety issue: No ]

    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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Santen Pharmaceutical Co., Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01363700     History of Changes
Other Study ID Numbers: 01141101
Study First Received: May 30, 2011
Results First Received: October 22, 2014
Last Updated: November 5, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on March 01, 2015