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

Hazleton Eye Specialists

Status: Completed

Conditions: Dry Eye Syndrome

Treatments: Other: No Intervention

Study type: Observational

Funder types: Other

Identifiers

NCT02522312

IIT-00864

Details and patient eligibility

About

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

Full 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

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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