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

Primary Purpose

Allergic Conjunctivitis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
DE-114 ophthalmic solution
Placebo ophthalmic solution
Olopatadine Hydrochloride 0.1% Ophthalmic Solution
Sponsored by
Santen Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Allergic Conjunctivitis

Eligibility Criteria

20 Years - 64 Years (Adult)All Sexes

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.

Sites / Locations

  • Santen study sites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Mean Ocular Itching Score Compared to Placebo Period1
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
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
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
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 .

Full Information

First Posted
May 30, 2011
Last Updated
November 5, 2014
Sponsor
Santen Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01363700
Brief Title
Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis
Official Title
Double-masked, Comparison Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3, Confirmatory Study -
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Santen Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis

7. Study Design

Study Phase
Phase 3
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
DE-114 ophthalmic solution
Other Intervention Name(s)
Epinastine ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Placebo ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Olopatadine Hydrochloride 0.1% Ophthalmic Solution
Primary Outcome Measure Information:
Title
Mean Ocular Itching Score Compared to Placebo Period1
Description
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 .
Time Frame
Visit 5 (3, 5, and 10 minutes post-CAC)
Title
Mean Hyperemia Score Compared to Placebo Period1
Description
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 .
Time Frame
Visit 5 (5, 10, and 20 minutes post-CAC)
Secondary Outcome Measure Information:
Title
Mean Ocular Itching Score Compared to Olopatadine Period2
Description
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 .
Time Frame
Visit 7 (3, 5, and 10 minutes post-CAC)
Title
Mean Hyperemia Score Compared to Olopatadine Period2
Description
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 .
Time Frame
Visit 7 (5, 10, and 20 minutes post-CAC)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Eligibility 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.
Facility Information:
Facility Name
Santen study sites
City
Osaka
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25163405
Citation
Fujishima H, Ohashi Y, Takamura E. Efficacy of epinastine hydrochloride ophthalmic solution in allergic conjunctivitis by conjunctival cedar pollen allergen challenge. Ann Allergy Asthma Immunol. 2014 Oct;113(4):476-81. doi: 10.1016/j.anai.2014.07.007. Epub 2014 Aug 20.
Results Reference
derived

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

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