Dry Eye Disease
Conditions
Brief summary
The objective of this retrospective chart review is to evaluate the patient characteristics, treatment variations and efficacy of a second trial of Cyclosporine Ophthalmic Emulsion 0.05% therapy in chronic dry eye patients who were initially treated with Cyclosporine Ophthalmic Emulsion 0.05% but discontinued use after less than 12 weeks of treatment.
Interventions
One drop two times a day approximately 12 hours apart
Sponsors
Allergan
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults \>16 years of age * Dry eye patients * Subject with history of less than 12 weeks of initial RESTASIS® treatment * Subject started second trial of RESTASIS® treatment prior to June 1, 2008 * First day of second trial of RESTASIS® started ≥ 4 weeks after the last day of previous RESTASIS® treatment
Exclusion criteria
* Patients with Contact Lens Intolerance * Patients with Ocular Rosacea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Complete Clearing of Corneal Staining at Month 12 | Month 12 | Percentage of patients with complete clearing of corneal staining at month 12. Corneal staining is evaluated following administration of fluorescein dye into the eye. Complete clearing is defined as the absence of corneal staining. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Schirmer's Test at Month 12 | Month 12 | Schirmer's test at month 12. The Schirmer's tear test is performed on the eye with or without anesthesia (numbing eye drop). The amount of tears produced by the eye in 5 minutes is measured in millimeters by means of a graduated paper scale. Data not reported due to limited number of patients with Schirmer's test data recorded. |
Countries
United States
Participant flow
Pre-assignment details
Retrospective analysis. Patients may have been treated with Restasis® (cyclosporine ophthalmic emulsion 0.05%) in addition to other medications during the course of the study.
Participants by arm
| Arm | Count |
|---|---|
| Patients Who Received Restasis® Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%) | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Patients Who Received Restasis® |
|---|---|
| Age, Customized <40 years | 7 participants |
| Age, Customized >=80 years | 2 participants |
| Age, Customized Between 40 and 49 years | 2 participants |
| Age, Customized Between 50 and 59 years | 8 participants |
| Age, Customized Between 60 and 69 years | 5 participants |
| Age, Customized Between 70 and 79 years | 11 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Percentage of Patients With Complete Clearing of Corneal Staining at Month 12
Percentage of patients with complete clearing of corneal staining at month 12. Corneal staining is evaluated following administration of fluorescein dye into the eye. Complete clearing is defined as the absence of corneal staining.
Time frame: Month 12
Population: ITT population, which consisted of all patients included in the study, with documented presence of corneal staining at baseline. For this outcome measure, a total of 18 patients had documented corneal staining at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Who Received Restasis® | Percentage of Patients With Complete Clearing of Corneal Staining at Month 12 | 33.3 Percentage of Patients |
Secondary
Schirmer's Test at Month 12
Schirmer's test at month 12. The Schirmer's tear test is performed on the eye with or without anesthesia (numbing eye drop). The amount of tears produced by the eye in 5 minutes is measured in millimeters by means of a graduated paper scale. Data not reported due to limited number of patients with Schirmer's test data recorded.
Time frame: Month 12
Population: ITT population, which consisted of all patients included in the study with Schirmer's testing data available at baseline. Data not reported due to limited number of patients with Schirmer's test data recorded.