An Observational Study of OPTIVE PLUS® for the Treatment of Dry Eye Disease
- 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
- Diagnosis of dry eye
- Physician decision to treat with OPTIVE PLUS® in accordance with the physician's standard practice
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description OPTIVE PLUS® OPTIVE PLUS® Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Score 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.