NCT01363713CompletedPhase 3
A Long-term Open-label Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3 -
Santen Pharmaceutical Co., Ltd.1 site in 1 country130 target enrollmentStarted: June 1, 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Change in Ocular Itching Score by Visit
Study Overview
Brief Summary
Safety and efficacy of DE-114 ophthalmic solution will be evaluated in patients with allergic conjunctivitis, in an open-label, multicenter study.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
Experimental
Intervention: DE-114 ophthalmic solution (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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