N/A
N=1,209
An Observational Study of OPTIVE PLUS® for the Treatment of Dry Eye Disease
Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT01711424 ↗Enrolled (actual)
1,209
Serious AEs
0.2%
Results posted
Mar 2014
Primary outcome: Primary: Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS® — 356; 746 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- OPTIVE PLUS® (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS® |
356; 746 | — |
| SECONDARY Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS® |
367; 734 | — |
| SECONDARY Tear Break Up Time (TBUT) |
7.0; 10.0 | — |
| SECONDARY Schirmer Score |
8.0; 10.0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01711424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.