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

Completed
Conditions
Dry Eye Syndromes
Interventions
Drug: OPTIVE PLUS®
Registration Number
NCT01711424
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1209
Inclusion Criteria
  • Diagnosis of dry eye
  • Physician decision to treat with OPTIVE PLUS® in accordance with the physician's standard practice
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Exclusion Criteria
  • None
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
OPTIVE PLUS®OPTIVE PLUS®Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
Primary Outcome Measures
NameTimeMethod
Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS®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
NameTimeMethod
Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS®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).

Tear Break Up Time (TBUT)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.

Schirmer ScoreBaseline, 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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