Phase 3
N=130
A Long-term Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT01363713 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Change in Ocular Itching Score by Visit — -0.6; -0.9; -1.3; -1.7 score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DE-114 ophthalmic solution (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Santen Pharmaceutical Co., Ltd.
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Ocular Itching Score by Visit |
-0.6; -0.9; -1.3; -1.7; -2.2 | — |
Summary
Safety and efficacy of DE-114 ophthalmic solution will be evaluated in patients with allergic conjunctivitis, in an open-label, multicenter study.
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.
Data sourced from ClinicalTrials.gov (NCT01363713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.