Phase 4 N=51 Treatment

Evaluation of Maintaining Visual Performance in Participants Who Engage in Electronic Visual Tasking While Using Restasis®

Dry Eye Syndromes

Bottom Line

View on ClinicalTrials.gov: NCT02554981 ↗

Enrolled (actual)

Serious AEs

6.0%

Results posted

Jun 2017

Primary outcome: Primary: Change From Baseline in the Total Corneal Staining Score With Fluorescein in the Worse Eye — 7.05; -1.51 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Cyclosporine 0.05% Ophthalmic Emulsion (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the Total Corneal Staining Score With Fluorescein in the Worse Eye	7.05; -1.51	—
PRIMARY Change From Baseline in the Total Conjunctival Staining Score With Fluorescein in the Worse Eye	4.57; -0.61	—
PRIMARY Change From Baseline in the Central Region Staining Score With Fluorescein in the Worse Eye	2.29; -0.75	—
PRIMARY Change From Baseline in the Total Corneal Staining Score With Lissamine Green in the Worse Eye	4.00; -0.34	—
PRIMARY Change From Baseline in the Total Conjunctival Staining Score With Lissamine Green in the Worse Eye	3.99; -0.18	—
PRIMARY Change From Baseline in the Central Region Staining Score With Lissamine Green in the Worse Eye	0.85; -0.24	—
PRIMARY Change From Baseline in Font Size	9.0; 0.0	—
PRIMARY Change From Baseline in Words Read Incorrectly	16.6; -4.1	—
PRIMARY Change From Baseline in Time to Read Passage	126.0; -0.7	—
PRIMARY Change From Baseline in Reading Rate	146.6; -3.6	—
SECONDARY Change From Baseline in Tear Film Break Up Time (TFBUT) in the Worse Eye	2.38; -0.31	—
SECONDARY Change From Baseline in Ocular Protection Index (OPI) 2.0 in the Worse Eye	1.38; -0.87	—
SECONDARY Change From Baseline in Interblink Interval (IBI) in the Worst Eye	5.27; -1.16	—
SECONDARY Change From Baseline in OSDI© Total Score	45.1; -14.9	—
SECONDARY Change From Baseline in Driving at Night on the OSDI©	1.7; -0.5	—
SECONDARY Change From Baseline in Working With a Computer or Bank Machine on the OSDI©	1.9; -0.8	—
SECONDARY Change From Baseline in Watching Television (TV) on the OSDI©	1.8; -0.9	—
SECONDARY Change From Baseline in Blurred Vision on the OSDI©	1.7; -0.6	—
SECONDARY Change From Baseline in Poor Vision on the OSDI©	1.5; -0.5	—
SECONDARY Change From Baseline in Reading on the OSDI©	1.5; -0.3	—
SECONDARY Change From Baseline in the Ocular Discomfort Scale Post Wilkins Test in the Worst Eye	3.08; -0.60	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02554981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.