Phase3 Study of DE-114A Ophthalmic Solution in Patients With Allergic Conjunctivitis
Phase 3
Completed
- Conditions
- Allergic Conjunctivitis
- Registration Number
- JPRN-jRCT2080223524
- Lead Sponsor
- SANTEN PHARMACEUTICAL CO., LTD.
- Brief Summary
The superiority of DE-114A ophthalmic solution (equivalent to 2 times a day) to placebo ophthalmic solution and non-inferiority to 0.05% epinastine hydrochloride ophthalmic solution (equivalent to 4 times a day) were verified. No adverse drug reaction and no safety issues were observed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 68
Inclusion Criteria
Provided signed, written informed consent.
Has a positive result from an allergen-specific IgE antibody test.
Exclusion Criteria
Eye disease other than allergic conjunctivitis is present and requires treatment.
Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Mean Ocular Itching Score <br>Mean Hyperemia Score
- Secondary Outcome Measures
Name Time Method efficacy<br>Ocular Itching Score<br>Hyperemia Score