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Completed

NCT Number: NCT01363713

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

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

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Santen study sites

Osaka, Japan

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DE-114 ophthalmic solution

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Santen Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Long-term Open-label Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3 -

Important dates

Primary completion
2012
First posted
Jun 1, 2011
Registry last updated
Oct 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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