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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02522312

Enrollment

102

Registered

2015-08-13

Start date

2015-09-30

Completion date

2015-12-31

Last updated

2016-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndrome

Keywords

Dry Eye

Brief summary

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

Detailed description

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

Interventions

OTHERNo Intervention

No drug is administered in this study

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
Improvement of Schirmer's Test score	6 months
Increased contact lens wear time	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026