Back to resultsA Long-term 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
Sponsored by
About this trial
This is an interventional trial for Allergic Conjunctivitis
Eligibility Criteria
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.
Sites / Locations
- Santen study sites
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Change in Ocular Itching Score by Visit
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01363713
First Posted
May 30, 2011
Last Updated
September 25, 2014
Sponsor
Santen Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01363713
Brief Title
A Long-term Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis
Official Title
A Long-term Open-label Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3 -
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Pharmaceutical Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
Safety and efficacy of DE-114 ophthalmic solution will be evaluated in patients with allergic conjunctivitis, in an open-label, multicenter study.
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
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DE-114 ophthalmic solution
Primary Outcome Measure Information:
Title
Change in Ocular Itching Score by Visit
Description
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.
Time Frame
From baseline to 8-week
Other Pre-specified Outcome Measures:
Title
Change in Palpebral Hyperemia Score by Visit
Description
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.
Time Frame
From baseline to 8-week
Title
Change in Bulbar Conjunctiva Hyperemia Score by Visit
Description
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.
Time Frame
From baseline to 8-week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Eligibility Criteria
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.
Facility Information:
Facility Name
Santen study sites
City
Osaka
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Long-term Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis
We'll reach out to this number within 24 hrs