Phase 3
N=87
Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT01363700 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Mean Ocular Itching Score Compared to Placebo Period1 — 0.4; 1.7 score — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DE-114 ophthalmic solution (Drug); Placebo ophthalmic solution (Drug); Olopatadine Hydrochloride 0.1% Ophthalmic Solution (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Santen Pharmaceutical Co., Ltd.
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Ocular Itching Score Compared to Placebo Period1 |
0.4; 1.7 | <0.001 sig |
| PRIMARY Mean Hyperemia Score Compared to Placebo Period1 |
2.7; 4.1 | <0.001 sig |
| SECONDARY Mean Ocular Itching Score Compared to Olopatadine Period2 |
0.2; 0.2; 1.5 | — |
| SECONDARY Mean Hyperemia Score Compared to Olopatadine Period2 |
2.4; 2.7; 3.7 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01363700). 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.