Phase 3 Study of DE-114A Ophthalmic Solution in Patients With Allergic Conjunctivitis
Phase 3
Completed
- Conditions
- Allergic Conjunctivitis
- Registration Number
- JPRN-jRCT2080223566
- Lead Sponsor
- SANTEN PHARMACEUTICAL CO., LTD.
- Brief Summary
DE-114A ophthalmic solution was instilled twice a day (morning and evening) for 8 weeks in subjects with allergic conjunctivitis. As a result, the safety and efficacy of long-term administration were confirmed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 121
Inclusion Criteria
Provided signed, written informed consent.
Has a positive result from a Type I allergy 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>Subjective symptom
- Secondary Outcome Measures
Name Time Method efficacy<br>Objective symptom