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

Completed

• Conditions: Dry Eye Syndrome

• Registration Number: NCT02522312
• Lead Sponsor: Hazleton Eye Specialists

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

Study Timeline

• Study First Submitted: 2015-07-29
• Study First Submitted QC: 2015-08-10
• Study First Posted: 2015-08-13
• Study Start: 2015-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of Schirmer's Test score	6 months
Increased contact lens wear time	6 months

Trial Locations

Locations (1)

Hazleton Eye Specialists; 🇺🇸 Hazleton, Pennsylvania, United States