NCT01118754
Completed
Phase 1
Phase I/II Prospective, Randomized, Double Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Compared to Placebo for the Treatment of Dry Eye Disease
ConditionsDry Eye
Overview
- Phase
- Phase 1
- Intervention
- DE-101 ophthalmic suspension
- Conditions
- Dry Eye
- Sponsor
- Santen Inc.
- Enrollment
- 132
- Primary Endpoint
- Ocular Symptom Severity
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
DE-101 ophthalmic suspension high dose
Intervention: DE-101 ophthalmic suspension
DE-101 ophthalmic suspension low dose
Intervention: DE-101 ophthalmic suspension
DE-101 ophthalmic suspension vehicle
Intervention: DE-101 ophthalmic suspension
DE-101 ophthalmic suspension vehicle
Intervention: DE-101 ophthalmic suspension vehicle
Outcomes
Primary Outcomes
Ocular Symptom Severity
Time Frame: 8 weeks
Total fluorescein corneal staining
Time Frame: 8 weeks
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