A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2015-12-31

Brief Summary

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A retrospective analysis of Restasis® benefits in dry eye contact lens patients.

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Detailed Description

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Charts of contact lens wearers with diagnosed dry eye who are being treated with Restasis will be evaluated to determine success in treatment by retrospectively looking at various outcome measures including but not limited to schirmer, staining and osmolarity levels

Conditions

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Dry Eye Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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No Intervention

No drug is administered in this study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or Female, \> or = 18 years of age
* Subject was previously diagnosed (prior to Baseline Visit) with mild to severe dry eye disease (ITF level 1, 2 or 3) which required continuous medical therapy with Restasis® for a minimum duration of 6 months post-Baseline (Visit 1); or Subject was newly diagnosed (at Baseline Visit) with mild to severe dry eye disease (ITF level 1, 2 or 3) which required continuous medical therapy with Restasis® for a minimum duration of 6 months post-Baseline (Visit 1);
* Subject was prescribed Restasis® therapy at Baseline Visit (Visit 1) and commenced dosing immediately after Baseline Visit (Visit 1)
* Baseline Visit occured between 01 July 2012 and 01 January 2014;
* Subject had corneal staining and at least one dry eye sign (i.e., Schirmer's Test score \<10 mm, decreased tear lake, TBUT \<10 seconds, conjunctival staining, tear osmolarity \>310 mOsmol/L
* Subject had charted tolerability and efficacy data reflecting at least one follow-up visit following Restasis® treatment initiation; and
* Subject wore contact lens(es) concurrently while receiving Restasis® treatment for a minimum duration of 6 months post-Baseline (Visit 1)