Dry Eye Syndromes
Conditions
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.
Interventions
DRUGOPTIVE PLUS®
Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of dry eye * Physician decision to treat with OPTIVE PLUS® in accordance with the physician's standard practice
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Participant flow
Pre-assignment details
Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice. There was no investigational drug administered in this study.
Participants by arm
| Arm | Count |
|---|---|
| OPTIVE PLUS® Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice. | 1,209 |
| Total | 1,209 |
Baseline characteristics
| Characteristic | OPTIVE PLUS® |
|---|---|
| Age, Customized 18 to 30 Years | 51 Participants |
| Age, Customized <18 Years | 3 Participants 15.89 |
| Age, Customized 31 to 40 Years | 94 Participants |
| Age, Customized 41 to 50 Years | 196 Participants |
| Age, Customized 51 to 60 Years | 230 Participants |
| Age, Customized 61 to 70 Years | 261 Participants |
| Age, Customized 71 to 80 Years | 269 Participants |
| Age, Customized 81 to 90 Years | 84 Participants |
| Age, Customized >= 91 Years | 5 Participants |
| Age, Customized Missing data | 16 Participants |
| Sex/Gender, Customized Female | 805 Participants |
| Sex/Gender, Customized Male | 398 Participants |
| Sex/Gender, Customized Missing Data | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,209 |
| serious Total, serious adverse events | 2 / 1,209 |
Outcome results
Primary
Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS®
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).
Time frame: Week 4
Population: All participants with data available for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OPTIVE PLUS® | Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS® | Very satisfied | 356 Participants |
| OPTIVE PLUS® | Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS® | Satisfied | 746 Participants |
Secondary
Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS®
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).
Time frame: Week 4
Population: All participants with data available for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OPTIVE PLUS® | Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS® | Very satisfied | 367 Participants |
| OPTIVE PLUS® | Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS® | Satisfied | 734 Participants |
Secondary
Schirmer Score
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.
Time frame: Baseline, Week 4
Population: All participants with complete data available for this outcome measure at Baseline and Week 4.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| OPTIVE PLUS® | Schirmer Score | Baseline | 8.0 mm/5 min |
| OPTIVE PLUS® | Schirmer Score | Week 4 | 10.0 mm/5 min |
Secondary
Tear Break Up Time (TBUT)
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.
Time frame: Baseline, Week 4
Population: All participants with complete data available for this outcome measure at Baseline and Week 4.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| OPTIVE PLUS® | Tear Break Up Time (TBUT) | Baseline | 7.0 Seconds |
| OPTIVE PLUS® | Tear Break Up Time (TBUT) | Week 4 | 10.0 Seconds |