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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01711424
First received: October 18, 2012
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Dry Eye Syndromes
Drug: OPTIVE PLUS®

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS® [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS® [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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).

  • Tear Break Up Time (TBUT) [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    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.

  • Schirmer Score [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    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.


Enrollment: 1209
Study Start Date: September 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with dry eye

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01711424

Locations
Germany
Stuttgart, Baden-Wuerttemberg, Germany
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01711424     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/DE/012
Study First Received: October 18, 2012
Results First Received: January 29, 2014
Last Updated: January 29, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

ClinicalTrials.gov processed this record on April 23, 2014