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

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ClinicalTrials.gov Identifier: NCT01711424
Recruitment Status : Completed
First Posted : October 22, 2012
Results First Posted : March 17, 2014
Last Update Posted : March 17, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

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.

Condition or disease Intervention/treatment
Dry Eye Syndromes Drug: OPTIVE PLUS®

Study Type : Observational
Actual Enrollment : 1209 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : September 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

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

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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01711424


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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01711424     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/DE/012
First Posted: October 22, 2012    Key Record Dates
Results First Posted: March 17, 2014
Last Update Posted: March 17, 2014
Last Verified: January 2014

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