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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-21

Study Completion Date

2016-03-24

Brief Summary

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

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Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RESTASIS®

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

Group Type EXPERIMENTAL

Cyclosporine 0.05% Ophthalmic Emulsion

Intervention Type DRUG

Cyclosporine 0.05% Ophthalmic Emulsion (RESTASIS®) 1 drop instilled in each eye twice a day.

Interventions

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Cyclosporine 0.05% Ophthalmic Emulsion

Cyclosporine 0.05% Ophthalmic Emulsion (RESTASIS®) 1 drop instilled in each eye twice a day.

Intervention Type DRUG

Other Intervention Names

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RESTASIS®

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No