Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
Phase 1
Completed
- Conditions
- Dry Eye
- Interventions
- Drug: DE-101 ophthalmic suspensionDrug: DE-101 ophthalmic suspension vehicle
- Registration Number
- NCT01118754
- Lead Sponsor
- Santen Inc.
- Brief Summary
The purpose of this study is to evaluate if DE-101 ophthalmic suspension will safely and effectively improve signs and or symptoms of dry eye disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
Inclusion Criteria
- confirmed diagnosis of dry eye defined by protocol
- 18 years or older, and sign written informed consent
- negative pregnancy test and utilizing reliable contraceptive throughout study
Exclusion Criteria
- use of any topical ocular medications
- any ocular surgery within 90 days of study
- laser refractive surgery within one year of study
- ocular, lid disease/abnormalities that may interfere with the study
- corneal transplants
- uncontrolled systemic conditions
- females who are pregnant or nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
- participated in another drug trial within 30 days prior to study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DE-101 ophthalmic suspension vehicle DE-101 ophthalmic suspension vehicle - DE-101 ophthalmic suspension high dose DE-101 ophthalmic suspension - DE-101 ophthalmic suspension low dose DE-101 ophthalmic suspension - DE-101 ophthalmic suspension vehicle DE-101 ophthalmic suspension -
- Primary Outcome Measures
Name Time Method Ocular Symptom Severity 8 weeks Total fluorescein corneal staining 8 weeks
- Secondary Outcome Measures
Name Time Method