Dry Eye Syndromes
Conditions
Brief summary
This is an observational, study of dry eye in patients at the consultation visit prior to LASIK surgery. There is no treatment administered or intervention during the study.
Interventions
OTHERNo Treatment
Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
Sponsors
Allergan
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Attending an ophthalmology consultation for LASIK
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients in Each Category of the Dry Eye Workshop Severity (DEWS) Scale | Day 1 | The severity of each patient's dry eye was classified by the physician according to the DEWS scale. Categories are: mild and/or episodic, occurs under environmental stress; moderate episodic or chronic, stress or no stress; and severe frequent or constant without stress |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Attending Consultation for LASIK Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study. | 400 |
| Total | 400 |
Baseline characteristics
| Characteristic | Patients Attending Consultation for LASIK |
|---|---|
| Age, Continuous | 29.7 Years STANDARD_DEVIATION 9.97 |
| Sex: Female, Male Female | 263 Participants |
| Sex: Female, Male Male | 137 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 in Each Category of the Dry Eye Workshop Severity (DEWS) Scale
The severity of each patient's dry eye was classified by the physician according to the DEWS scale. Categories are: mild and/or episodic, occurs under environmental stress; moderate episodic or chronic, stress or no stress; and severe frequent or constant without stress
Time frame: Day 1
Population: All enrolled patients
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Patients Attending Consultation for LASIK | Percentage of Patients in Each Category of the Dry Eye Workshop Severity (DEWS) Scale | Mild and/or episodic, occurs under stress | 65.0 Percentage of Patients | 25.97 |
| Patients Attending Consultation for LASIK | Percentage of Patients in Each Category of the Dry Eye Workshop Severity (DEWS) Scale | Moderate episodic or chronic, stress or no stress | 29.0 Percentage of Patients | — |
| Patients Attending Consultation for LASIK | Percentage of Patients in Each Category of the Dry Eye Workshop Severity (DEWS) Scale | Severe frequent or constant without stress | 4.2 Percentage of Patients | — |
| Patients Attending Consultation for LASIK | Percentage of Patients in Each Category of the Dry Eye Workshop Severity (DEWS) Scale | Data unavailable | 1.8 Percentage of Patients | — |