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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01711424
Other study ID # MAF/AGN/OPH/DE/012
Secondary ID
Status Completed
Phase N/A
First received October 18, 2012
Last updated January 29, 2014
Start date September 2012
Est. completion date March 2013

Study information

Verified date January 2014
Source Allergan
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

This is an observational study of OPTIVE PLUS® in patients with dry eye disease in a routine clinical setting. Treatment decisions are made by the physician and reflect the physician's current standard of care.


Recruitment information / eligibility

Status Completed
Enrollment 1209
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of dry eye

- Physician decision to treat with OPTIVE PLUS® in accordance with the physician's standard practice

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
OPTIVE PLUS®
Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS® Patients rated their satisfaction with OPTIVE PLUS® as treatment for dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied). Week 4 No
Secondary Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS® The physician rated their satisfaction with OPTIVE PLUS® for the treatment of their patient's dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied). Week 4 No
Secondary Tear Break Up Time (TBUT) TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The longer it takes, the more stable the tear film. Baseline, Week 4 No
Secondary Schirmer Score The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. Baseline, Week 4 No
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