Clinical trial NCT02554981: Evaluation of Maintaining Visual Performance in Participants Who Engage in Electronic Visual Tasking While Using Restasis®
Official title: Evaluation of Maintaining Visual Performance Of Subjects Who Engage in Electronic Visual Tasking While Using Restasis (EMPOWER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-09-21
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy of Restasis® in participants with dry eye disease who engage in electronic visual tasking.


Eligibility criteria: Inclusion:

* Has Eye Symptoms when using video display terminals
* Has a reported history of dry eye in both eyes.

Exclusion:

* Diagnosed with eye infection or active inflammation.
* Has worn contact lenses within the past 7 days or anticipated use during the study.
* Has used any eye drops within 2 hours.
* Has had laser-assisted in situ keratomileusis (LASIK) within 12 months.
* Has used Restasis® within 90 days.
* Has had any eye and or/lid surgeries within 6 months.
* Has had cataract surgery in either eye.
* Has current punctal occlusion or anticipate a change in punctal occlusion status at any point during the study.
* Is currently taking any topical ophthalmic prescriptions or over-the-counter solutions, artificial tears, gels or lid scrubs that cannot be discontinued for the trial duration.
* Use of medication known to cause ocular drying that is not on a stable dose for at least 30 days.

Primary outcomes:
measure: Change From Baseline in the Total Corneal Staining Score With Fluorescein in the Worse Eye
timeFrame: Baseline, Month 6
measure: Change From Baseline in the Total Conjunctival Staining Score With Fluorescein in the Worse Eye
timeFrame: Baseline, Month 6
measure: Change From Baseline in the Central Region Staining Score With Fluorescein in the Worse Eye
timeFrame: Baseline, Month 6
measure: Change From Baseline in the Total Corneal Staining Score With Lissamine Green in the Worse Eye
timeFrame: Baseline, Month 6
measure: Change From Baseline in the Total Conjunctival Staining Score With Lissamine Green in the Worse Eye
timeFrame: Baseline, Month 6
measure: Change From Baseline in the Central Region Staining Score With Lissamine Green in the Worse Eye
timeFrame: Baseline, Month 6
measure: Change From Baseline in Font Size
timeFrame: Baseline, Month 6
measure: Change From Baseline in Words Read Incorrectly
timeFrame: Baseline, Month 6
measure: Change From Baseline in Time to Read Passage
timeFrame: Baseline, Month 6
measure: Change From Baseline in Reading Rate
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Change From Baseline in Tear Film Break Up Time (TFBUT) in the Worse Eye
timeFrame: Baseline, Month 6
measure: Change From Baseline in Ocular Protection Index (OPI) 2.0 in the Worse Eye
timeFrame: Baseline, Month 6
measure: Change From Baseline in Interblink Interval (IBI) in the Worst Eye
timeFrame: Baseline, Month 6
measure: Change From Baseline in OSDI© Total Score
timeFrame: Baseline, Month 6
measure: Change From Baseline in Driving at Night on the OSDI©
timeFrame: Baseline, Month 6
measure: Change From Baseline in Working With a Computer or Bank Machine on the OSDI©
timeFrame: Baseline, Month 6
measure: Change From Baseline in Watching Television (TV) on the OSDI©
timeFrame: Baseline, Month 6
measure: Change From Baseline in Blurred Vision on the OSDI©
timeFrame: Baseline, Month 6
measure: Change From Baseline in Poor Vision on the OSDI©
timeFrame: Baseline, Month 6
measure: Change From Baseline in Reading on the OSDI©
timeFrame: Baseline, Month 6
measure: Change From Baseline in the Ocular Discomfort Scale Post Wilkins Test in the Worst Eye
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates, Inc
state: Massachusetts
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
Study officials:
affiliation: Allergan
name: Jai Parekh
role: STUDY_DIRECTOR
References: