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Completed

NCT Number: NCT01363700

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

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.

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Key information

Conditions

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

Age range

20 year–64 year

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 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.

Treatment and study plan

DE-114 ophthalmic solution

Drug

Other names: Epinastine ophthalmic solution

Placebo Ophthalmic Solution

Drug

Olopatadine hydrochloride 0.1% ophthalmic solution

Drug

Primary outcomes

  1. 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 .

  2. 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 outcomes

  1. 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 .

  2. 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 .

Sponsors and collaborators

Lead sponsor

Santen Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Double-masked, Comparison Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3, Confirmatory Study -

Important dates

Primary completion
2012
First posted
Jun 1, 2011
Registry last updated
Nov 19, 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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