An Observational Study of OPTIVE PLUS® for the Treatment of Dry Eye Disease

Dry Eye Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711424
• Other study ID #: MAF/AGN/OPH/DE/012
• 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

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

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