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NCT01118754 Clinical Trial

Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients

Dry Eye Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01118754
Other study ID # 26-004
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received April 29, 2010
Last updated November 1, 2011
Start date April 2010
Est. completion date December 2010

Study information
Verified date November 2011
Source Santen Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• DE-101 ophthalmic suspension
Ophthalmic suspention; QID
• DE-101 ophthalmic suspension
Ophthalmic suspension; QID
• DE-101 ophthalmic suspension vehicle
ophthalmic suspension vehicle; QID

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Santen Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Total fluorescein corneal staining 8 weeks
Primary Ocular Symptom Severity 8 weeks
See also
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