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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00667004
Other study ID # CL-S&E-1107071-P
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 22, 2008
Est. completion date September 12, 2008

Study information

Verified date August 2020
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Efficacy study of ecabet ophthalmic solution in dry eye disease


Recruitment information / eligibility

Status Completed
Enrollment 183
Est. completion date September 12, 2008
Est. primary completion date September 12, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosed with dry eye disease

Exclusion Criteria:

- Dry eye disease secondary to surgery

Study Design


Intervention

Drug:
ecabet ophthalmic solution
sterile ophthalmic solution
placebo
sterile ophthalmic solution

Locations

Country Name City State
United States ISTA Pharmaceuticals, Inc. Irvine California

Sponsors (1)

Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change From Baseline in Lacrimation Assessed by Schirmer's Test The Schirmer's test is used determine if tear glands produce enough tears to keep eyes adequately moist. Calibrated strips of a non-toxic filter paper are used. One free end is placed within the lower eyelid. At the conclusion of the test, the paper strip is removed from the lower eyelid and the amount of wetting of the paper strip is measured. 43 days
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