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

Allergan

Status and phase: Completed; Phase 4

Conditions: Dry Eye Syndromes

Treatments: Drug: Cyclosporine 0.05% Ophthalmic Emulsion

Study type: Interventional

Funder types: Industry

Identifiers

NCT02554981

MA-RES-015-001

Details and patient eligibility

About

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

Enrollment: 51 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

51 participants in 1 patient group

RESTASIS®

Experimental group

Description:

1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.

Treatment:

Drug: Cyclosporine 0.05% Ophthalmic Emulsion