NCT01711424

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,209

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1 year until next milestone

Results Posted

Study results publicly available

March 17, 2014

Completed
Last Updated

March 17, 2014

Status Verified

January 1, 2014

Enrollment Period

6 months

First QC Date

October 18, 2012

Results QC Date

January 29, 2014

Last Update Submit

January 29, 2014

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS®

    Week 4

  • Tear Break Up Time (TBUT)

    Baseline, Week 4

  • Schirmer Score

    Baseline, Week 4

Study Arms (1)

OPTIVE PLUS®

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

Drug: OPTIVE PLUS®

Interventions

OPTIVE PLUS®DRUG

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

OPTIVE PLUS®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with dry eye

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Stuttgart, Baden-Wurttemberg, Germany

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Vice President Medical Affairs,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2012

First Posted

October 22, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 17, 2014

Results First Posted

March 17, 2014

Record last verified: 2014-01

Locations

DE(1)