Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | April 2010 |
| End Date: | December 2010 |
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
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.
effectively improve signs and or symptoms of dry eye disease.
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
We found this trial at
10
sites
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