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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: April 11, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Eye Diseases
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Patient Satisfaction with OPTIVE® Plus Using a 4-Point Scale [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physician Satisfaction with OPTIVE® Plus Using a 4-Point Scale [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Tear Break Up Time (TBUT) [ Time Frame: Baseline, 4 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Schirmer Score [ Time Frame: Baseline, 4 Weeks ] [ Designated as safety issue: No ]

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
Patients with Dry Eye
Patients with dry eye prescribed OPTIVE® Plus in accordance with physician standard practice. All treatment decisions lie with the physician.
 Drug: OPTIVE® Plus
Patients with dry eye prescribed OPTIVE® Plus in accordance with physician standard practice. All treatment decisions lie with the physician.

  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
Last Updated: April 11, 2013
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 June 17, 2013