NCT02554981: EMPOWER

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

Completed Phase 4 Results posted Last updated 1 June 2017

What this trial tests

Phase 4 trial testing Cyclosporine 0.05% Ophthalmic Emulsion in Dry Eye Syndromes in 51 participants. Completed in 24 March 2016.

Timeline

21 July 2015

Primary endpoint
24 March 2016

24 March 2016

Quick facts

Lead sponsor	Allergan
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	51
Start date	21 July 2015
Primary completion	24 March 2016
Estimated completion	24 March 2016
Sites	2 locations across United States

Drugs / interventions tested

• Cyclosporine 0.05% Ophthalmic Emulsion — full drug profile →

Conditions studied

• Dry Eye Syndromes — all drugs for Dry Eye Syndromes →

Sponsor

Allergan — full company profile →

Who can join

Adults 18 to 55, any sex, with Dry Eye Syndromes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in the Total Corneal Staining Score With Fluorescein in the Worse Eye Primary · Baseline, Month 6

Total corneal staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).

Baseline

Group	Value	95% CI
RESTASIS®	7.05	± 1.011

Change from Baseline at Month 6

Group	Value	95% CI
RESTASIS®	-1.51	± 1.466

Change From Baseline in the Total Conjunctival Staining Score With Fluorescein in the Worse Eye Primary · Baseline, Month 6

Total conjunctival staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).

Baseline

Group	Value	95% CI
RESTASIS®	4.57	± 1.237

Change from Baseline at Month 6

Group	Value	95% CI
RESTASIS®	-0.61	± 1.238

Change From Baseline in the Central Region Staining Score With Fluorescein in the Worse Eye Primary · Baseline, Month 6

Staining with fluorescein in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).

Baseline

Group	Value	95% CI
RESTASIS®	2.29	± 0.441

Change from Baseline at Month 6

Group	Value	95% CI
RESTASIS®	-0.75	± 0.656

Change From Baseline in the Total Corneal Staining Score With Lissamine Green in the Worse Eye Primary · Baseline, Month 6

Total corneal staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).

Baseline

Group	Value	95% CI
RESTASIS®	4.00	± 1.378

Change from Baseline at Month 6

Group	Value	95% CI
RESTASIS®	-0.34	± 1.418

Change From Baseline in the Total Conjunctival Staining Score With Lissamine Green in the Worse Eye Primary · Baseline, Month 6

Total conjunctival staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).

Baseline

Group	Value	95% CI
RESTASIS®	3.99	± 1.486

Change from Baseline at Month 6

Group	Value	95% CI
RESTASIS®	-0.18	± 1.235

Change From Baseline in the Central Region Staining Score With Lissamine Green in the Worse Eye Primary · Baseline, Month 6

Staining with lissamine green in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).

Baseline

Group	Value	95% CI
RESTASIS®	0.85	± 0.822

Change from Baseline at Month 6

Group	Value	95% CI
RESTASIS®	-0.24	± 0.524

Change From Baseline in Font Size Primary · Baseline, Month 6

The minimum font (letter) size read correctly was assessed. Smaller font size (less points) indicates better ability. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening.

Baseline

Group	Value	95% CI
RESTASIS®	9.0	± 0.00

Change from Baseline at Month 6

Group	Value	95% CI
RESTASIS®	0.0	± 0.21

Change From Baseline in Words Read Incorrectly Primary · Baseline, Month 6

The numbers of words read incorrectly are counted. A positive change from Baseline indicates a worsening (more words read incorrectly) and a negative change from Baseline indicates an improvement.

Baseline

Group	Value	95% CI
RESTASIS®	16.6	± 22.00

Change from Baseline at Month 6

Group	Value	95% CI
RESTASIS®	-4.1	± 16.64

Change From Baseline in Time to Read Passage Primary · Baseline, Month 6

The time to read passage (selected portion of text ) in seconds was assessed. A negative change from Baseline indicates an improvement (less time to read the passage).

Baseline

Group	Value	95% CI
RESTASIS®	126.0	± 28.64

Change from Baseline at Month 6

Group	Value	95% CI
RESTASIS®	-0.7	± 24.48

Change From Baseline in Reading Rate Primary · Baseline, Month 6

Reading speed was assessed as the number of words read correctly calculated as words/minute. A positive change from Baseline indicates an improvement (more words read correctly/minute) and a negative change from Baseline indicates a worsening (less words read correctly/minute).

Baseline

Group	Value	95% CI
RESTASIS®	146.6	± 64.18

Change from Baseline at Month 6

Group	Value	95% CI
RESTASIS®	-3.6	± 69.80

Change From Baseline in Tear Film Break Up Time (TFBUT) in the Worse Eye Secondary · Baseline, Month 6

TFBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. The worse eye is defined as the Worse Eye at Baseline. A positive number change from Baseline indicates improvement and a negative number change from Baseline indicates a worsening.

Baseline

Group	Value	95% CI
RESTASIS®	2.38	± 1.073

Change from Baseline at Month 6

Group	Value	95% CI
RESTASIS®	-0.31	± 1.258

Change From Baseline in Ocular Protection Index (OPI) 2.0 in the Worse Eye Secondary · Baseline, Month 6

A device was used to assess OPI 2.0. This technology measures blink and tear film break-up area. These values demonstrate the average area of tear deficiency/corneal exposure. The worse eye is defined as the worse eye at Baseline. A negative value indicates an improvement in corneal protection.

Baseline

Group	Value	95% CI
RESTASIS®	1.38	± 2.064

Change from Baseline at Month 6

Group	Value	95% CI
RESTASIS®	-0.87	± 1.975

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RESTASIS®

Serious: 3/50 (6%)

Deaths: —

Serious adverse events (3 terms)

Reaction	System	RESTASIS®
Papillary thyroid carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Peripheral vascular disease	Vascular disorders	—
Carbon monoxide poisoning	Injury, poisoning and procedural complications	—

Other adverse events (2 terms — click to expand)

Reaction	System	RESTASIS®
Visual acuity reduced	Eye disorders	—
Nasopharyngitis	Infections and infestations	—

Most-reported serious reactions: Papillary thyroid carcinoma, Peripheral vascular disease, Carbon monoxide poisoning.

Data from ClinicalTrials.gov NCT02554981 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.