Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-03

Study Completion Date

2014-09-23

Brief Summary

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This study will evaluate the safety and efficacy of cyclosporine 0.05% ophthalmic emulsion (Restasis®) in patients with dry eye disease.

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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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cyclosporine 0.05% ophthalmic emulsion

Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.

Group Type EXPERIMENTAL

cyclosporine 0.05% ophthalmic emulsion

Intervention Type DRUG

Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily for 6 months.

carboxymethylcellulose-based lubricant eye drops

Intervention Type DRUG

Carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.

Interventions

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cyclosporine 0.05% ophthalmic emulsion

Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily for 6 months.

Intervention Type DRUG

carboxymethylcellulose-based lubricant eye drops

Carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.

Intervention Type DRUG

Other Intervention Names

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Restasis® Refresh OPTIVE® Advanced

Eligibility Criteria

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Inclusion Criteria

* History of dry eye in both eyes
* Willing to use eye drops for dry eye symptoms

Exclusion Criteria

* Anticipate wearing contact lenses during the study
* Laser-assisted in situ keratomileusis (LASIK) surgery within the past 12 months
* Any ocular and/or lid surgeries within the past 6 months
* Cataract surgery in either eye
* Current or anticipated use of temporary punctal plugs during the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No