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

January 29, 2014 updated by: Allergan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1209

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Wuerttemberg
      • Stuttgart, Baden-Wuerttemberg, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with dry eye

Description

Inclusion Criteria:

  • Diagnosis of dry eye
  • Physician decision to treat with OPTIVE PLUS® in accordance with the physician's standard practice

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OPTIVE PLUS®
Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
Drug: OPTIVE PLUS®
Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS®
Time Frame: Week 4
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS®
Time Frame: Week 4
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
Tear Break Up Time (TBUT)
Time Frame: Baseline, Week 4
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
Schirmer Score
Time Frame: Baseline, Week 4
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

October 18, 2012

First Submitted That Met QC Criteria

October 18, 2012

First Posted (Estimate)

October 22, 2012

Study Record Updates

Last Update Posted (Estimate)

March 17, 2014

Last Update Submitted That Met QC Criteria

January 29, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAF/AGN/OPH/DE/012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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