Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease

Innovative Medical

Status and phase: Completed; Phase 4

Conditions: Treatment of Dry Eye Disease

Treatments: Drug: Restasis, Refresh Plus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00567177

HSC-MS-07-0421

Details and patient eligibility

About

We propose to investigate the response to Restasis, over a prolonged period of time in heavy computer users with dry eye disease.

Enrollment: 40 estimated patients

Sex: All

Ages: 13+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Using computers more than three hours per day
• Having dry eye symptoms based on results on the OSDI Scores of 15 or greater on the OSDI will be considered to have the disorder
• An abnormal confocal image of 5 or greater.

Exclusion criteria

• All corneal disorders except for tear disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: Restasis, Refresh Plus

2

Placebo Comparator group

Treatment:

Drug: Restasis, Refresh Plus