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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Eye Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on October 20, 2014