Trial Outcomes & Findings for An Observational Study of Dry Eye Prior to Laser-Assisted in Situ Keratomileusis (LASIK) Therapy (NCT NCT01854905)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

400 participants

Primary outcome timeframe

Day 1

Results posted on

2014-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Attending Consultation for LASIK Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
Overall Study STARTED	400
Overall Study COMPLETED	400
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Observational Study of Dry Eye Prior to Laser-Assisted in Situ Keratomileusis (LASIK) Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Attending Consultation for LASIK n=400 Participants Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
Age, Continuous	29.7 Years STANDARD_DEVIATION 9.97 • n=5 Participants
Sex: Female, Male Female	263 Participants n=5 Participants
Sex: Female, Male Male	137 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: All enrolled patients

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

Outcome measures

Outcome measures
Measure	Patients Attending Consultation for LASIK n=400 Participants Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
Percentage of Patients in Each Category of the Dry Eye Workshop Severity (DEWS) Scale Data unavailable	1.8 Percentage of Patients
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
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
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

Adverse Events

Patients Attending Consultation for LASIK

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER