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

Dry Eye Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522312
• Other study ID #: IIT-00864
• Status: Completed
• Phase: N/A
• First received: July 29, 2015
• Last updated: March 1, 2016
• Start date: September 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Hazleton Eye Specialists
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Other:
• No Intervention
No drug is administered in this study

Locations

Country	Name	City	State
United States	Hazleton Eye Specialists	Hazleton	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Hazleton Eye Specialists

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of Schirmer's Test score		6 months	No
Primary	Increased contact lens wear time		6 months	No