Status:
COMPLETED
Safety and Efficacy Study of DE-110 Ophthalmic Suspension for the Treatment of Dry Eye Disease
Lead Sponsor:
Santen Inc.
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Investigate the Safety and Efficacy of Two Concentrations of DE-110 Compared to Placebo for the Treatment of Dry Eye Disease
Eligibility Criteria
Inclusion
- Confirmed diagnosis of dry eye
- Not wear contact lenses during study
- 18 years or older
- Understand and provide written consent
- Negative pregnancy test and use acceptable method of contraception
Exclusion
- Use of any topical ocular medication
- Any type of ocular surgery
- Diagnosis of on-going ocular infection and/or allergic conjunctivitis
- Uncontrolled systemic conditions/lid abnormalities
- Corneal transplants
- Females who are pregnant, nursing or planning a pregnancy
- Participation in another drug trial concurrently or within 30 days prior to study
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01239069
Start Date
November 1 2010
End Date
October 1 2011
Last Update
May 21 2014
Active Locations (14)
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1
Inglewood, California, United States
2
Newport Beach, California, United States
3
Petaluma, California, United States
4
Torrance, California, United States